BEUDAMED
    FDA Adverse Event Other Summary report: N

    CROSSVENT

    MDR report key: 343212 · Received July 17, 2001

    Report

    Report Number
    1218704-2001-00001
    Event Type
    Other
    Date Received
    July 17, 2001
    Date of Event
    June 13, 2001
    Report Date
    July 13, 2001
    Manufacturer
    BIO-MED DEVICES, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED 'VENTILATOR IN USE STARTED FLASHING (LCD), THEN SCREEN WENT BLANK, STOPPED VENTILATING'. NO INJURY TO THE PATIENT. (FAIL-TO-CYCLE ALARM ACTIVATED) UNIT IN TRANSPORT, RUN ON BATTERY, SANS CHARGER. AFTER EVALUATION AND DISCUSSION, REALIZED USERS HAD IGNORED AUDIBLE AND VISUAL "LOW BATTERY" ALARMS; NO ONE KNEW ANYTHING ABOUT BATTERY MAINTENANCE (IN LABELING). UNIT RECEIVED BACK- BATTERY ALMOST DEAD (0 VOLTS). BATTERY NEEDED CHARGING- ALL FUNCTIONS FINE WITH EXTERNAL CHARGER ATTACHED. FINE RUNNING ON BATTERY AFTER CHARGE. DID CDC MAINTENANCE ON BATTERY AND OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32423 CROSSVENT VENTILATOR CBK BIO-MED DEVICES, INC. CV-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *