GE Healthcare
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1. water into the equipment do not mount the Patient Data Module in a vertical position with the patient cables facing up or down 482A Mounting options include mounting to a bed headboard or footboard an IV pole or a roll stand using one of the docking stations Mounting kits include all necessary hardware and installation instructions Page 4 of 42. GE Healthcare Healthcare Systems 9900 Innovation Drive URGENT Field Safety Notice oo April 2014 GEHC Ref 36096 To Healthcare Administrator Risk Manager Chief of Nursing Director of Biomedical Engineering RE Patient Data Module PDM Top Cover Heat Buildup GE Healthcare has recently become aware of a potential safety issue due to fluid ingress into the top cover assembly which can result in heat buildup Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions Safety Fluid can pass through the seals in the top cover and come into contact with Issue energized contacts in the circuit board This can result in heat buildup smoke and discoloration This heat buildup could potentially result in thermal injury to a patient or caregiver Safety Inspect the top cover for signs of heat buildup or discoloration If there is evidence Instructions of this discontinue use In order to minimize the potential risk of injury do not spray the device with fluid For cleaning follow Section 5 of PDM Service Manual Also do not mount the PDM in a vertical position as noted in Section 3 of the service manual see below Affected Product All PDM s produced from April 2007 through June 2010 encompassing Fiscal Details Week FW 13 2007 through FW 26 2010 Manufactured date can be determined from the serial number which is located on the bottom of the unit The 4 a
3. nd 5 digit are the year and the 6 and 7 digit are the Fiscal Week The affected product code is SA3 Example a unit with serial number SA31035XXXXXX was manufactured in Fiscal Week 35 in 2010 Product GE Healthcare will provide a new top cover at no charge once it is available We will Correction contact you to arrange for installation of the top cover Contact If you have any questions regarding this notification please contact Technical Information Support or your local Service Representative Please be assured that maintaining a high level of safety and quality is our highest priority If you have any questions please contact us immediately per the contact information above Sincerely Vice President QARA Chief Medical Officer GE Healthcare Systems GE Healthcare Cleaning Precautions Maintenance Improper cleaning methods can result in degradation of the equipment performance and or failure To avoid damage to the equipment Never use conductive solutions solutions that contain chlorides wax or wax compounds to clean the equipment Never immerse equipment in any liquid Never pour or spray any liquid on the equipment or permit fluid to seep into connections or openings Never autoclave or steam clean the equipment Never use the following solutions acetone Bentadine ketone alcohol based cleaners sodium salts abrasive cleaners or any type of Ammonium Chloride such as Dimethyl Benzyl Ammonium Chloride o
4. r Quaternary Ammonium Chloride Never connect the device to a patient until it is thoroughly dry Permitted cleaning agents Cleaning procedures Water Mild soap diluted Clorox Bleach Active ingredient 5 25 Sodium Hypochlorite Off the shelf Mix 10 1 with H20 Any sodium hypochlorite wipe product that meets the above guidelines Sagrotan dilution 3 100 containing 75 mg tartaric acid per 100 ml solution CAUTION Failure to follow these rules may melt distort or dull the finish of the case blur lettering on the labels or cause equipment failures Remove power all cables and batteries Close the battery door Dampen a soft lint free cloth with one of the permitted cleaning agents Wring excess liquid from the cloth and wipe the exterior surface NOTE Contact of disinfectant solutions with metal parts may cause corrosion Do not damage or bend connector pins when cleaning or drying Maintenance Storage Allow solution to remain on device for a minimum of one minute or per hospital guidelines Do not let fluid pool around connection pins If this happens blot dry with a cotton swab or soft cloth Shake out excess liquids from connector recesses Wipe off cleaning solution with a clean moist cloth Dry thoroughly with a clean dry lint free cloth and let air dry for at least 30 minutes Do not apply heat NOTE Drying times may vary based on the environmental conditions Remove batte
5. ries when the device is not in use even for short periods of time Store in a dry well ventilated area Hang the device using a holder if available If leadwires or cables are attached hang them straight Do not coil leadwires or cables tightly around the device Consequences of using improper cleaning product Appearance of waveforms when the device is not connected to a patient causing false alarms instead of a leads fail alarm and possibly not providing a visual or audible leads fail alarm Brittle and breaking device case Overall system performance degradation Melting dulling or distorting the case Total medical device failure requiring replacement Unit malfunction Void warranty Cleaning products to avoid Cleaning products known to cause the types of problems listed above include but are not limited to Sani Cloth Wipes Ascepti Wipes HB Quat Clorox Wipes they do not contain bleach Over the counter detergents e g Fantastic Tilex etc Products that contain active ingredients and solutions similar to these products should also be avoided Page 3 of 4 WARNING WARNING Installation PHYSICAL INJURY Do not hang articles on the IV pole that are not related to the Patient Data Module s use Do not place the Patient Data Module more than 147 cm 58 in from the floor when mounting on an IV pole with a base not less than 58 cm 23 in in diameter To reduce the ingress of
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