BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIRD 6400 ST VENTILATOR

    MDR report key: 35323 · Received July 23, 1996

    Report

    Report Number
    35323
    Event Type
    Malfunction
    Date Received
    July 23, 1996
    Date of Event
    July 11, 1996
    Report Date
    July 23, 1996
    Manufacturer
    BIRD PRODUCTS CORP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING VENTILATED IN SIMV MODE. PT BEING SUCTIONED WHEN MACHINE SHUT DOWN; PT UNHARMED. MED STAFF PRESENT AND PROVIDED MANUAL RESPIRATION ALONG WITH SPONTANEOUS RESP. SVC REP REPORTED THAT INSULATION FROM CABINET HAD BECOME DISLODGED AND BLOCKED. COOLING FAN CAUSING OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD 6400 ST VENTILATOR VENTILATOR CBK BIRD PRODUCTS CORP. 09611

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR