BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1250423 · Received September 5, 2008

    Report

    Report Number
    9611500-2008-00027
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    BSZ
    PMA / PMN Number
    k011404
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS SENT TO ANSWER THE USER FACILITY REPORT. AS REPORTED IN THE ABOVE MENTIONED MDR A DRAEGER SVC REP FOUND DURING HIS EVAL IN THE HOSP THAT THE LOWER DIAPHRAGM OF THE VENTILATOR WAS ASSEMBLED WRONGLY DURING MANUFACTURING. A WRONGLY INSTALLED LOWER DIAPHRAGM CAN LEAD TO A VENTILATOR FAIL AFTER SOME TIME IN USE. IN CASE OF A VENTILATOR FAIL CONDITION THE DEVICE WILL ALARM OPTICALLY AND ACOUSTICALLY. MANUAL VENTILATION WITH THE DEVICE AND THE DEVICE MONITORING ARE FULLY FUNCTIONAL. THE ERROR CODES FOUND IN THE DEVICE ERROR LOG CONFIRMED THE VENTILATOR FAILURE AND INDICATE THAT THE DEVICE REACTED AS SPECIFIED. THE DRAEGER TECH EXCHANGED THE VENTILATOR AND CHECKED THE DEVICE SUCCESSFULLY ACCORDING TO THE DRAEGER CERTIFICATE. IN CONTEXT OF THE WARRANTY, COMPLAINT AND SVC SURVEILLANCE NO OTHER CASES OF WRONGLY INSTALLED DIAPHRAGMS DURING MFG WERE KNOWN. THE ASSEMBLING PROCESS DOCUMENTATION IS SUFFICIENT. THE REPORTED PROBLEM IS ASSESSED TO BE A SINGLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ANESTHESIA WORKSTATION BSZ DRAEGER MEDICAL AG & CO. KG * NA

    Patients

    Seq Age Sex Outcome Treatment
    1