BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS

    MDR report key: 496377 · Received November 13, 2003

    Report

    Report Number
    2517967-2003-00156
    Event Type
    Malfunction
    Date Received
    November 13, 2003
    Date of Event
    November 11, 2003
    Report Date
    November 11, 2003
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN INVESTIGATION OF A RETURNED APL VALVE AT DRAEGER MEDICAL, INC., IT WAS NOTED THAT THE APL VALVE CAME APART DURING PERFORMANCE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. GS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA