BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR

    MDR report key: 115040 · Received August 25, 1997

    Report

    Report Number
    MW1011935
    Event Type
    Malfunction
    Date Received
    August 25, 1997
    Date of Event
    August 3, 1997
    Report Date
    August 14, 1997
    Manufacturer
    KOBELCO NORTHWEST
    Product Code
    KPJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    COMPRESSOR ON HBO CHAMBER DID NOT WORK NECESSITATING USE OF BACK-UP. PT WAS ABLE TO CONTINUE TREATMENT IN A SUCCESSFUL EFFORT TO SAVE AMPUTATED FINGERS. FAILURE OF COMPRESSOR HAS OCCURRED SEVERAL TIMES OVER LAST FEW MONTHS. FAILURE SEEMS TO BE RELATED TO SLUDGE IN THE OIL LINE POSSIBLY RELATED TO THE CHILLED WATER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSOR COMPRESSOR KPJ KOBELCO NORTHWEST * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR