BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED S9 SLIM LINE TUBING

    MDR report key: 2010429 · Received March 2, 2011

    Report

    Report Number
    MW5019660
    Event Type
    Injury
    Date Received
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    RESMED
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RESMED CPAP VENTILATION HOSES ARE FAILING. PLASTIC HOSE/TUBING IS TEARING NEAR THE JOINTS. THIS IS ALLOWING AIR TO ESCAPE AND COULD RENDER THE CPAP INEFFECTIVE THUS CAUSING LONG TERM INJURY TO THE PT. I HAVE EXPERIENCED TUBING FAILURES ON TWO (2) TUBES, BOTH A SLIMLINE TUBE AND A CLIMATELINE TUBE. MY PROVIDER HAS VERBALIZED THEY ARE AWARE OF MULTIPLE FAILURES, BEYOND THIS PT, RESULTING IN A LIMITED RESUPPLY STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED S9 SLIM LINE TUBING CPAP -VENTILATION OR AIR SUPPLY- TUBES BZD RESMED SLIM
    2 RESMED S9 CLIMATE LINE TUBING CPAP -VENTILATION OR AIR SUPPLY- TUBES BZD RESMED CLIMATE

    Patients

    Seq Age Sex Outcome Treatment
    1