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1. should carry out the following measures All MEDUMAT Transport devices must be verifiably updated with the new XC firmware version 2 35 and embedded PC Version 2 35 Both firmware update files are available to download free of charge for all update authorised customers in the login area on our website www weinmann emergency de for this purpose a Install the firmware update V 2 35 on all your devices You can download the instructions for carrying out the firmware update together with the update files b Please notify us of the update for the specific device by clicking on the corresponding button in the login area c If you do not have update authorisation your update authorised retailer or a Weinmann employee will be in touch with you shortly so that you may discuss how to proceed There are no functional modifications to the operation of the device from the previous versions linked to the firmware update V 2 35 You can continue to use your MEDUMAT Transport devices until the update has been installed But we ask that you and your employees note the recommendation below Please ensure that this safety information is brought to the attention of all users of the above mentioned products and other people to be informed in your organisation If you have sold the products to third parties this applies to retailers for example please forward a copy of this information and where appropriate to your customers Please use the attached2. Henstedt Ulzburg Register Court District Court of Hamburg Dept A no 115967 VAT ID no DE288367727 WEEE reg no DE 47913245 Certified QM system EC Directive 93 42 EEC Annex II EN ISO 9001 EN ISO 13485 General Partner WEINMANN Emergency Management GmbH Hamburg Register Court District Court of Hamburg Dept B no 38144 Creditor ID DE35ZZZ00000353971 Managing Directors Dipl Volksw Marc Griefahn Dipl Kfm Philipp Schroeder Dipl Volksw Andr Schulte Bank details Deutsche Bank AG Hamburg Sort code 700 00 Acc no 646963900 SWIFT DEUTDEHH IBAN DE87200700000646963900 Hamburger Sparkasse AG Sort code 200 505 50 Acc no 1032262667 SWIFT HASPDEHHXXX IBAN DE44200505501032262667 Commerzbank AG Hamburg Sort code 200 400 00 Acc no 632007100 SWIFT COBADEHHXXX IBAN DE14200400000632007 100 Page 2 of 4 partner for life WEINM ANN medicalMtechnology Addition to the instructions for use In chapter 10 Troubleshooting of the instructions for use you will find appropriate recommendations for various potential faults in the device Your instructions for use are hereby extended in chapter 10 2 as follows Message Alarm Cause Rectification High Device internal 1 Switch off the device Chapter 5 12 Ending Device priority fault ventilation malfunction 2 Switch on the device again Chapter 5 2 Switching the unit on Self test 3 Select Previous patien
3. device software V 2 35 This optimises the internal device monitoring eliminating the above mentioned cause for the device malfunction error message Please note that in the event of actual device malfunctions e g defect valve etc your device will continue to show the device malfunction error message properly in future WEINMANN Emergency Register Court General Partner Managing Directors Hamburger Sparkasse AG Medical Technology GmbH Co KG District Court of Hamburg WEINMANN Emergency Dipl Volksw Marc Griefahn Sort code 200 505 50 Acc no 1032262667 Frohb sestraRe 12 22525 Hamburg Dept A no 115967 Management GmbH Hamburg Dipl Kfm Philipp Schroeder SWIFT HASPDEHHXXX T 040 88 18 96 0 VAT ID no DE288367727 Register Court Dipl Volksw Andr Schulte IBAN DE44200505501032262667 F 040 88 18 96 480 WEEE reg no DE 47913245 District Court of Hamburg Bank details Commerzbank AG Hamburg E info weinmann emt de Dept B no 38144 Deutsche Bank AG Hamburg Sort code 200 400 00 Acc no 632007100 www weinmann emergency de Certified QM system Sort code 700 00 Acc no 646963900 SWIFT COBADEHHXXX Zentrum fiir Produktion Logistik Service Siebenstiicken 14 24558 Henstedt Ulzburg EC Directive 93 42 EEC Annex II EN ISO 9001 EN ISO 13485 Creditor ID DE35ZZZ00000353971 SWIFT DEUTDEHH IBAN DE87200700000646963900 IBAN DE14200400000632007100 Page 1 of 4 partner for life WEINM ANN medicalMtechnology You
4. p Schroeder SWIFT HASPDEHHXXX T 040 88 18 96 0 VAT ID no DE288367727 Register Court Dipl Volksw Andr Schulte IBAN DE44200505501032262667 F 040 88 18 96 480 WEEE reg no DE 47913245 District Court of Hamburg Bank details Commerzbank AG Hamburg E info weinmann emt de Dept B no 38144 Deutsche Bank AG Hamburg Sort code 200 400 00 Acc no 632007100 www weinmann emergency de Certified QM system Sort code 700 00 Acc no 646963900 SWIFT COBADEHHXXX Zentrum fiir Produktion Logistik Service Siebenstiicken 14 24558 Henstedt Ulzburg EC Directive 93 42 EEC Annex II EN ISO 9001 EN ISO 13485 Creditor ID DE35ZZZ00000353971 SWIFT DEUTDEHH IBAN DE87200700000646963900 IBAN DE14200400000632007100 Page 3 of 4 Reply to WEINMANN Emergency concerning the safety information MEDUMAT Transport adjustment to device software and user manual of 27 09 2013 The original letter was sent to Please complete this reply form in full and send it per fax e mail or post to Fax 49 40 88 18 96 25492 E mail vigilance weinmann emt de WEINMANN Emergency Medical Technology GmbH Co KG Safety Officer for Medical Devices Frohboesestrasse 12 22525 Hamburg GERMANY Please complete in full in block capitals O Company details are identical to those of the addressee above O Company details differ to those of the addressee as follows Your customer no Company address O I hereby confirm receipt of this let
5. partner for life WEINM ANN medicalMtechnology WEINMANN Emergency Medical Technology GmbH Co KG Postfach 57 01 53 22770 Hamburg Germany Hamburg 27 September 2013 Important safety note corrective measure for a medical device already on the market MEDUMAT Transport adjustment to device software and user manual Dear Sir or Madam Quality and safety are our highest priority For that reason as ever we would like to take a consistent and transparent approach and ask for your assistance in implementing a corrective measure to further increase the stability of the MEDUMAT Transport Sender WEINMANN Emergency Medical Technology GmbH Co KG Addressees Users and operators of MEDUMAT Transport as well as retail partners Identification of the medical devices concerned MEDUMAT Transport ventilator with and without CO measurement All serial numbers are affected Description of the problem including the determined cause In some cases MEDUMAT Transport ventilators have failed as a result of a device internal fault There is the potential risk of this fault recurring sporadically in future too Cause In the interaction of the internal structural components and sensors for internal device monitoring device internal occurrences of this kind may coincide unfavourably resulting in an undefined operating state and the device displaying a device malfunction for safety reasons Corrective action We have developed new
6. reply form to confirm receipt of this letter or that is has been forwarded Recommendation When the error message device malfunction appears switch the MEDUMAT Transport ventilator off and back on again immediately after Proceed as follows to do so 1 Hold down the On Standby Off button for 2 seconds to switch the device to standby Chapter 5 12 Ending ventilation Immediately after switching off press the On Standby Off button to restart the device again Chapter 5 2 Switching the unit on Self test In the Start menu press the Previous patient button The unit begins ventilation in the mode that was last selected and with the parameters last set Chapter 5 2 Switching the unit on Self test Doing this suspends the running ventilation for approx 30 seconds If the device malfunction which occurred was due to an undefined operating state as described above then the device will be ready for operation again after switching off and on If the device malfunction recurs upon restarting the device then it is not a question of an undefined operating state but an actual technical defect In this case the device is no longer fit for use You will need to have the device repaired WEINMANN Emergency Medical Technology GmbH Co KG Frohb sestraRe 12 22525 Hamburg T 040 88 18 96 0 F 040 88 18 96 480 E info weinmann emt de www weinmann emergency de Zentrum fiir Produktion Logistik Service Siebenstiicken 14 24558
7. t and continue ventilation Chapter 5 2 Switching the unit on Self test 4 lf the fault persists have the device repaired Contact If you have any questions please do not hesitate to contact your local specialist dealer or us directly We will be happy to answer any questions you may have If required please feel free to contact your Area Manager or our Technical Service tel 49 40 88 18 96 122 e mail AfterSalesService weinmann emt de Yours sincerely WEINMANN Emergency Medical Technology GmbH Co KG 0 amp p p Dr Ralf Egenolf Authorised signatory Head of Quality Management and Regulatory Affairs Andr Schulte Managing Director Organisational information Please note WEINMANN Emergency Medical Technology GmbH Co KG is the legal successor of the Emergency business unit of WEINMANN Ger te f r Medizin GmbH Co KG which originally launched the devices on to the market WEINMANN Emergency has retained all the customers addresses and delivery territories of the Emergency business unit in order for this safety information to be addressed to all users of MEDUMAT Transport WEINMANN Emergency Register Court General Partner Managing Directors Hamburger Sparkasse AG Medical Technology GmbH Co KG District Court of Hamburg WEINMANN Emergency Dipl Volksw Marc Griefahn Sort code 200 505 50 Acc no 1032262667 Frohb sestraRe 12 22525 Hamburg Dept A no 115967 Management GmbH Hamburg Dipl Kfm Philip
8. ter and that have read and understood its content This letter has been brought to the attention of all users of the product and other people to be informed in my organisation If the products have been passed on to third parties e g applies to specialist dealers a copy of this information will be conveyed to them Date signature Name in block capitals Position in block capitals E mail in block capitals Page 4 of 4
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