BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAEGER MEDICAL, DISTRIBUTED BY ABBOTT LABORATORIES

    MDR report key: 562565 · Received December 10, 2004

    Report

    Report Number
    MW1033980
    Event Type
    Other
    Date Received
    December 10, 2004
    Report Date
    December 10, 2004
    Manufacturer
    DRAEGER MEDICAL
    Product Code
    CAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DRAEGER VAPOR 2000 VAPORIZORS USED W/FABIUS ANESTHESIA MACHINES, BOTH SERVOFLURANE AND ISOFLURANE: CHRONIC FAILURES, LEAKS, CAUSED BY DEGENERATED SEAL GASKETS AND JAMMED FILL PORT MECHANISMS. HAVE HAD 14 VAPORIZER FAILURES UNDER WARRANTY IN 6 MOS. FOUND DEGRADED SEAL GASKETS AND/OR JAMMED FILL PORT MECHANISMS IN UNITS EXAMINED PRIOR TO RETURNING FOR WARRANTY EXCHANGE. HAVE EXP DELAYS IN GETTING REPLACEMENTS DUE TO BACKORDERS. DRAEGER CONFIRMED THEY ARE AWARE OF BOTH PROBLEMS. JAMMED MECHANISMS DUE TO PROBLEM WITH LATCH MECHANISM - IF LATCH IS CLOSED ALL THE WAY DURING FILL PROCESS CAUSES JAMMING. GASKET PROBLEM IS DUE TO CHANGE MADE BY SUPPLIER OF GASKET. DRAEGER HAS PROVIDED NOTIFICATION OF THESE PROBLEMS ONLY THROUGH THEIR SVC NOTES AVAILABLE ONLY TO PAID SUBSCRIBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER MEDICAL, DISTRIBUTED BY ABBOTT LABORATORIES ANESTHESIA VAPORIZER CAD DRAEGER MEDICAL VAPOR 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other