BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESMED CORP

    MDR report key: 1429337 · Received July 24, 2009

    Report

    Report Number
    MW5012128
    Event Type
    Malfunction
    Date Received
    July 24, 2009
    Date of Event
    June 22, 2009
    Report Date
    July 24, 2009
    Manufacturer
    RESMED CORP
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    CPAP DEVICE # DEVELOPED ELECTRICAL SHORT IN POWER SUPPLY - RESMED POWER SUPPLIES FOR ALL 2005 AND MANY 2006 DEVICES WERE RE-CALLED AS A VOLUNTARY MEASURE BUT RESMED CONTINUES TO PUT OUT POTENTIALLY DANGEROUS - FIRE BREEDING DEVICES - THEY HAVE NOT FIXED THE PROBLEM - RATHER SEEMED TO BE JUST APPEASING THE MARKET WITH AN INEFFECTIVE RE-CALL WHILE LEAVING DANGEROUS DEVICES TO FAIL. DATES OF USE: 2006 TO 2009. DIAGNOSIS OR REASON FOR USE: OSA. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED CORP CPAP-58 SERIES BZD RESMED CORP 58 20060581091

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR