BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT VENTILATOR CIRCUIT

    MDR report key: 32044 · Received April 17, 1996

    Report

    Report Number
    MW1008881
    Event Type
    Injury
    Date Received
    April 17, 1996
    Date of Event
    April 4, 1996
    Report Date
    April 9, 1996
    Manufacturer
    BIOMED DEVICES, INC.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE VENTILATOR CYCLES, THE PRESSURE GAUGE WOULD NOT READ. INVESTIGATION FOUND A THIN COVER WAS ON THE ADAPTER GOING TO THE PRESSURE GAUGE. CIRCUIT WAS PULLED AND THE MFR WAS NOTIFIED. ALL CIRCUITS WITH THE SAME LOT # WERE PULLED. THE VENTILATOR WAS BEING USED FOR NEONATAL TRANSPORT. AGE AT TIME OF EVENT: FEW HOURS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT VENTILATOR CIRCUIT PATIENT VENTILATOR CIRCUIT BZO BIOMED DEVICES, INC. 0710 3095, 07011896

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Life Threatening