BEUDAMED
    FDA Adverse Event Other Summary report: N

    BEAR MEDICAL/BIRD PRODUCTS CORPORATION

    MDR report key: 228214 · Received June 9, 1999

    Report

    Report Number
    MW1016559
    Event Type
    Other
    Date Received
    June 9, 1999
    Date of Event
    May 26, 1999
    Report Date
    May 28, 1999
    Manufacturer
    BEAR MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ON A BIRD 6400 VENTILATOR AND IT FAILED. THE ALARM DID NOT ACTIVATE. THE SVC CO RESPONDED AND INSPECTED THE VENTILATOR. SUSPECTED FAILURE WAS DUE TO A SECONDARY FUSE WHICH HAD BLOWN OUT. TECH STATED THAT THE FAILED FUSE WAS ALSO THE REASON THE ALARM DID NOT ACTIVATE. TECH STATED THAT THIS WAS NOT THE FIRST TIME THIS HAS HAPPENED TO THIS MODEL MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR MEDICAL/BIRD PRODUCTS CORPORATION BIRD VENTILATOR 6400 CBK BEAR MEDICAL SYSTEMS, INC. 6400ST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other