BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2023050-2008-00077

    MDR report key: 1269219 · Received November 11, 2008

    Report

    Report Number
    2023050-2008-00077
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Product Code
    CBK
    PMA / PMN Number
    K992133
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: INVESTIGATION CONFIRMED THE REPORTED PROBLEM "IT (VENTILATOR) IS NOT TURNING ON" DUE TO THE INTERNAL BATTERY BEING EMPTY. HOWEVER, THE OTHER PROBLEM "VENTILATOR IS SHUTTING DOWN WITH NO WARNING" WAS NOT CONFIRMED. DURING THE EVAL, IT WAS NOTICED THAT THE POWER SAVE MODE SETTING ON THE VENTILATOR WAS OFF. NOTE: IF THE POWER SAVE MODE IS NOT ON, IT SLOWLY DISCHARGES THE BATTERY. THE VENTILATOR WAS PLUGGED INTO AC POWER TO CHARGE FOR 8 HOURS. THE BATTERY CHARGE AND DISCHARGE CYCLES WERE MONITORED AND IT WAS CONFIRMED THAT THE BATTERY FELL INTO TRICKLE CHARGE WITHIN 5 MINUTES AFTER THE CHARGE TEST WAS INITIATED WITHOUT ANY PROBLEMS. THE DISCHARGE TEST WAS ALSO PROCEEDED WITHOUT FURTHER ISSUE. THE VENTILATOR OPERATED ON INTERNAL BATTERY FOR 11 HOURS AND 15 MINUTES WITHOUT SHUTTING DOWN. ALL THE ALARMS INITIATED DURING DISCHARGE TEST. THE BATTERY WAS RECHARGED FOR 8 HOURS AFTER THE TEST. THE VENTILATOR TURNS ON NORMALLY BOTH ON AC POWER AND INTERNAL BATTERY. CALIBRATION AND OPERATION VERIFICATION PROCEDURE WERE PERFORMED AND THE VENTILATOR PASSED ALL TESTS. H6. THE REPORTED PROBLEM, "VENTILATOR IS SHUTTING DOWN WITN NO WARNING" WAS NOT DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBK

    Patients

    Seq Age Sex Outcome Treatment
    1