H017-101-343_0 PAD recall March 2013 Customer
Contents
1. RESERVE PAD PAK ON HAND 7 When you receive the hang tag attach it to the handle of the Samaritan 300 300P PAD soft carrying case to alert a first responder that they may need to replace the installed depleted PAD PAK with the reserve PAD PAK contained in the zippered pouch Instructions for replacing the PAD PAK are provided on the hang tag 8 When you receive the CD data cable and User Manual your device must be connected to a USB port in your computer so that the current version of the software can be downloaded The software can also be downloaded from http www heartsine com recall software_updates Either the CD or the link will automatically update your device to the appropriate version of the battery management software Replace the originally supplied User Manual stored in the soft carry case with the new copy supplied with this field action 9 If you need your device in a sudden cardiac arrest event and the LED is red or unlit replace the PAD PAK with the reserve PAD PAK according to the instructions on the hang tag Once the reserve PAD PAK has been inserted you will be able to deliver therapy Following the event contact Think Safe at 1 319 377 5125 or toll free at 1 888 473 1777 immediately so that we may make sure that you have the ability to provide therapy in the future H017 101 343 0 Page 3 of 5 U S Americas 121 Friends Lane Suite 400 Newtown PA 18940 P 215 860 8100 F 215 860 8192 www heartsine co2. our device status checks to daily Upon receipt we will o Place the reserve 1500 mAh PAD PAK in the zippered portion of the soft carrying case o Place the hang tag on the soft carrying case handle o Update the device s software using the supplied CD or the website download using the data cable supplied o Replace the originally supplied User Manual stored in the soft carrying case with the new copy supplied with this field action Device serial number s Facility Name Facility Address O Check if you would like the equipment sent to the above address or provide address below Completed By Title Signature Date Phone No Facsimile No Email Preferred form of contact Email O Phone O Fax H017 101 343 0 Page 5 of 5 U S Americas 121 Friends Lane Suite 400 Newtown PA 18940 P 215 860 8100 F 215 860 8192 www heartsine com EMEA ASP 203 Airport Road West Belfast Northern Ireland BT3 9ED P 44 0 28 90 93 94 00 F 44 0 28 90 93 94 01
3. 343 0 Page 1of5 U S Americas 121 Friends Lane Suite 400 Newtown PA 18940 P 215 860 8100 F 215 860 8192 www heartsine com EMEA ASP 203 Airport Road West Belfast Northern Ireland BT3 9ED P 44 0 28 90 939400 F 44 0 28 90 93 94 01 HeartSine Inventor Innovator Lifesaver e Issue 2 Battery Management Software Issue Certain Samaritan 300 300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery This issue will result in the device prematurely displaying the low battery warning and turning itself off even though sufficient battery capacity remains This may occur when the device performs its weekly self test or when the device is turned on or when the device is preparing to deliver a shock or after delivering a shock If the low battery warning is triggered due to this issue the device will have sufficient power to deliver multiple shocks but it is possible that the device may not deliver any shocks or it may only deliver one shock before turning itself off If this occurs delivery of any subsequent shocks may be delayed and would likely only be delivered at the lowest energy level of 150 Joules Once the device has experienced this condition it is more likely to experience it again This condition can occur when the installed PAD PAK has already been partially depleted due to normal battery depletion or where th
4. HeartSine Inventor Innovator Lifesaver URGENT MEDICAL DEVICE RECALL Samaritan 300 300P PAD March 4 2013 Dear Valued Customer This letter is to inform you of a voluntary global correction to certain of HeartSine Technologies Ltd s Samaritan 300 300P PAD public access defibrillators This correction will address two separate issues that could affect your ability to deliver therapy to a patient in a sudden cardiac arrest SCA event if needed By completing the actions described in this letter your device s will have a new battery to be held in reserve and the most current version of the software which includes the latest battery management software involved in this correction HeartSine s records indicate you have received a product that is affected by this action To ensure that you are always able to deliver therapy during a sudden cardiac arrest event as soon as possible after we receive your response form indicating where you would like your equipment shipped we will arrange to supply you 1 a 1500 mAh PAD PAK to be held in reserve in the zippered pouch on the back of your device 2 a data cable and CD so that you can upgrade the current version of the device software 3 a hang tag for your device that will instruct users how to install the reserve PAD PAK should the current PAD PAK appear to lack sufficient battery power during a patient event and 4 a new user manual to reflect the software version you wil
5. ble to provide therapy in the event that a SCA event occurs 1 DO NOT remove your device s from service 2 If necessary relocate the Samaritan 300 300P PAD to an area where the audible prompts would be heard if initiated If the device turns itself on and off OR if your device displays a Low Battery Warning before the expiry date labelled on the PAD PAK in the device contact Think Safe at 1 319 377 5125 or toll free at 1 888 473 1777 immediately so that we may make sure that you have the ability to provide therapy in the future confirm that the Samaritan 300 300P PAD is operable and in ready standby mode as indicated by a flashing green LED see the HeartSine i Samaritan PAD SAM 300 300P User Manuals ial 4 Confirm that the LED light is flashing green If the LED is red or unlit contact Think Safe at 1 319 377 5125 or toll free at 1 888 473 17777 immediately so that we may send you a replacement unit 3 Immediately increase the frequency of your device checks to daily to a D 5 Return the attached response form indicating that you have received and understand this communication and indicating where you would like Think Safe to ship your equipment i e reserve PAD PAK CD data cable user manual and hang tag 6 When you receive the 1500 mAh PAD PAK insert it in the zippered pouch on the back of the Samaritan 300 300P PAD soft carrying case so that it may be held in reserve if needed MAKE SURE YOU ALWAYS HAVE A
6. e installed PAD PAK is an 800 mAh capacity battery This software version was distributed until the end of December 2010 Devices containing software versions 1 4 2 3 2 0 or higher are not susceptible to this issue Samaritan 300 300P PAD devices with the following serial numbers inclusive are affected by one or both these issues Please note that a typo error has been e 0400000501 to 0700032917 corrected in this serial number it was e 08A00035000 to 10A00070753 lt ___ 10A0070753 Please ensure this does e 10 00200000 to 10C00210106 not affect any other devices in your possession No other HeartSine automated external defibrillator products are affected by either issue No deaths or injuries have been reported to date associated with the on off issue To date HeartSine has received five reports of death for which the company has not been able to rule out the possibility that the events may have been related to the battery management software issue This recall is being made with the knowledge of the U S Food and Drug Administration H017 101 343 0 Page 2 of 5 U S Americas 121 Friends Lane Suite 400 Newtown PA 18940 P 215 860 8100 F 215 860 8192 www heartsine com EMEA ASP 203 Airport Road West Belfast Northern Ireland BT3 9ED P 44 0 28 90 9394 00 F 44 0 28 90 93 94 01 HeartSine Inventor Innovator Lifesaver Please take the following actions to ensure that you are a
7. l now be using Based on information available to date certain Samaritan 300 300P PAD devices may experience one or both of the following conditions that could affect your ability to deliver therapy to a patient in a SCA event if needed e Issue 1 On Off Issue The device may turn itself on and off without input from the user When this occurs the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitted from the device If the device does not detect that the audible prompts are followed e g a patient is connected to the electrodes to allow the device to read the patient s ECG and start the normal sequence of events the device will automatically switch off after 10 minutes to save power This sequence of on off events can happen repeatedly or intermittently If this condition is undetected the battery will eventually become completely depleted In worst case situations it is possible that the battery could be depleted below the minimum battery capacity to allow for the delivery of therapy within a week However a device experiencing this issue will be capable of delivering therapy provided that an adequate power source is available As further explained below a 1500 mAh PAD PAK to be held in reserve is provided for this purpose Devices potentially subject to the on off issue were manufactured between August 2004 and December 2010 and have a warranted life of 7 years H017 101
8. m EMEA ASP 203 Airport Road West Belfast Northern Ireland BT3 9ED P 44 0 28 90 93 94 00 F 44 0 28 90 93 94 01 HeartSine Inventor Innovator Lifesaver If you have further distributed this product please notify your customers at once of this communication or provide your consignee list in an Excel file and we will send a direct notification to your customers within that consignee list that have not already been notified You can email this customer list directly to mmaly think safe com If you do not have email capabilities please call 1 319 377 5125 or toll free at 1 888 473 1777 for alternative ways to supply your customer list This recall should be carried out to the user level Your assistance is appreciated and necessary to ensure that you are able to provide therapy to SCA patients Please complete and return the enclosed response form as soon as possible If you have any questions call Think Safe at 1 319 377 5125 or toll free at 1 888 473 1777 At HeartSine the lifesaving legacy we began in 1967 remains a passion that drives all of our employees today We are committed to working with you in partnership in providing public safety at the highest levels and we thank you for your business and continued support We regret the inconvenience this may cause you We value you and your patients and appreciate your understanding as we work to ensure that we are providing you with the life saving devices you have come to rel
9. y upon Sincerely Declan O Mahoney President and CEO HeartSine Technologies Ltd H017 101 343 0 Page 4 of 5 U S Americas 121 Friends Lane Suite 400 Newtown PA 18940 P 215 860 8100 F 215 860 8192 www heartsine com EMEA ASP 203 Airport Road West Belfast Northern Ireland BT3 9ED P 44 0 28 90 9394 00 F 44 0 28 90 93 94 01 HeartSine Inventor Innovator Lifesaver URGENT MEDICAL DEVICE RECALL Samaritan 300 300P PAD RESPONSE FORM Please assist us in making this Medical Device Recall Notification follow up process efficient and convenient for you by completing and returning this form to Think Safe via email or fax which serves as a confirmation that you have received and understand this notification Also please indicate where you would like your equipment shipped A cover sheet is not required You can also download this form on our website at www HeartSine com recall FAX 1 319 377 4224 E MAIL mmaly think safe com If you have questions please call Think Safe at 1 319 377 5125 or toll free at 1 888 473 1777 between 8 00 am to 5 00 pm CST Monday through Friday Please complete this form by checking the applicable boxes indicating that you understand and have taken or will take the recommended actions We have checked our device s and the low battery warning is not displayed We have relocated the device s to an area where the audible prompts would be heard if initiated We are increasing
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