BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1243188 · Received November 18, 2008

    Report

    Report Number
    9611500-2008-00040
    Event Type
    Other
    Date Received
    November 18, 2008
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS THE ANSWER TO USER FACILITY REPORT: THE VENTILATOR WAS INVESTIGATED BY THE MFR, IT WAS NOT POSSIBLE TO REPRODUCE THE REPORTED BEHAVIOR, THE VENTILATOR WAS FOUND TO MEET THE SPEC. ALSO THE DEVICE LOG INVESTIGATION SHOWED NO TECHNICAL PROBLEMS. THE ANALYSIS OF THE LOGBOOK DEMONSTRATED THAT AT THE REPORTED TIME OF EVENT A SUCTION PROCEDURE WAS STARTED BY THE USER. DURING THIS PROCEDURE THE VENTILATOR DOES NEITHER DELIVER ANY BREATHS TO THE PT NOR SHOW A FLOW OR PRESSURE WAVE FORM. THIS WAS THE BEHAVIOR REPORTED BY THE USER. THE LOG INVESTIGATION CONFIRMED THAT THE SUCTION HAS BEEN FINISHED DUE TO THE IMPLEMENTED TIMEOUT FUNCTION AFTER 2 MINUTES, THE DEVICE ALARMED AND RESTARTED THE VENTILATION. THE DEVICE WAS SWITCHED OFF BY THE USER AT THE SAME TIME. THE SUCTION PROCEDURE IS EXPLAINED PROPERLY IN THE DEVICE USER MANUAL. IT CAN BE CONCLUDED THAT NO DEVICE MALFUNCTION LEAD TO THE REPORTED SITUATION, THE COMPLAINT WILL BE CLOSED, NO FURTHER MEASURES ARE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL AG & CO. KG * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN