BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAR

    MDR report key: 120058 · Received September 16, 1997

    Report

    Report Number
    2022747-1997-00127
    Event Type
    Malfunction
    Date Received
    September 16, 1997
    Report Date
    September 15, 1997
    Manufacturer
    ALLIED HEALTHCARE
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE INSPECTED THE VENTILATOR AND DETERMINED THAT THE MODE SELECT PCB WAS THE CAUSE OF THE PSV FAILURE. LAB TEST: TEST THE PCB IN A TEST UNIT SHOWED NO PROBLEMS WITH THE PSV BREATH DELIVERY.

    Description of Event or Problem · 1

    PSV WORKING INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR VOLUME VENTILATOR CBK ALLIED HEALTHCARE BEAR 3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN