Dräger Medical

Aneasthesia Machines

Fabius GS Premium , Tiro,Tiro D-M , MRI , plus and plus XL Important Safety Notice Feb 2018

Recall

Potential failure of Automatic and Manual Ventilation of Fabius devices

5 Pages

Dräger Drägerwerk AG & Co... GaA, 23542 Lübeck To our customers of the Dräger anesthesia machines Fabius GS Premium, Tiro, Tiro D-M, MRI, plus, plus XL February 2018 Important safety notice!!! Potential failure of automatic and manual Ventilation of Fabius devices... ffected are only Fabius devices with the serial numbers specified in the enclosure... ther anesthesia devices are NOT affected! Dear Sir/Madam, As part of our global market monitoring, we have become aware of a case in which the automatic Ventilation of a Fabius failed during Operation... entilation of the patient was continued by means of the ManSpont mode and a manual resuscitator... o injury was reported... ur investigation revealed that in this individual case excess oil from a production step interfered with the position detection of the Ventilator motor during Operation... e cannot completely rule out that the devices specified in the enclosure also contain excess oil which may, in the worst case, interfere with the position detection of the Ventilator motor... ccording to our records, you have been supplied with one or more of the devices with the affected serial numbers... If the position detection of the motor is disturbed, the automatic Ventilation may fail and the device alerts the user by displaying the message "VENTILATOR FAIL!!!"... lthough this has not occurred yet, manual Ventilation may also fail if the Ventilator cover is damaged... e are currently producing replacement motors for the potentially affected devices... ur Dräger Service will contact you and arrange an appointment for replacing the motor, free of Charge... Drägerwerk AG & Co... GaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address: 23542 Lübeck, Germany Tel... 49 451 882-0 Fax +49 451 882-2080 info@draeger... m www... aeger... m VATID: DE135082211 Bank information: Commerzbank AG, Lübeck IBAN: DE95 2304 0022 0014 6795 00 SWIFT code: COBA DE FF 230 Sparkasse zu Lübeck IBAN: DE15 2305 0101 0001 0711 17 SWIFT code: NOLADE21SPL Company headquarters: Lübeck Commercial register: Municipal Court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG • Company headquarters: Lübeck Commercial register: Municipal Court Lübeck HRB 7395 HL Chairman of the Executive Board of Drägerwerk AG & Co... GaA and Drägerwerk Verwaltungs AG: Prof... r... ikolaus Schweickart Board of Directors: Stefan Dräger (Chairman) Rainer Klug Gert-Hartwig Lescow Dr... einer Piske Anton Schrofner Dräger Page 2/2 Until then, please continue to operate your devices with the usual attention and make sure that a manual resuscitator for emergency Ventilation is kept ready according to our instructions for use... e regret any inconveniences this may cause... With best regards, Hans Ulrich Schüler Head of Product Management Anesthesiölogy Post Market Surveillance Quality and Regulatory Affairs
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