BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPAP III ST - ASIA PACIFIC

    MDR report key: 1976382 · Received January 28, 2011

    Report

    Report Number
    3004604967-2011-00006
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    July 5, 2009
    Report Date
    January 28, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K030843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ERROR LOG AND COMPLIANCE DATA HAD NO EVIDENCE OF AUTOMATIC SHUTDOWN. THE DEVICE PASSED PRESSURE AND FLOW CALIBRATION TESTS AND THE BLOWER PERFORMANCE TEST. DEVICE OPERATION WAS TESTED USING THE REPORTED SETTINGS WITH A RESMED HUMIDIFIER AND THE EXHALATION PORT SUPPLIED BY THE CUSTOMER. THE DEVICE PERFORMED TO SPECIFICATION WHEN OPERATED AT TIDAL VOLUMES WITHIN THE INTENDED USE, WITH NO EVIDENCE OF AUTO TRIGGERING OR AUTOMATIC SHUTDOWN. THE COMPLAINT INDICATED THAT THE DEVICE WAS USED WITH A THIRD PARTY HUMIDIFIER AND EXHALATION PORT ON AN (B)(6) TRACHEOTOMY NMD PATIENT FOR INVASIVE VENTILATION IN A LIFE SUPPORT ENVIRONMENT. ALL OF THESE FACTORS ARE CONTRAINDICATED IN THE USE OF THIS DEVICE. TWO 24 HOUR TESTS WERE CONDUCTED TO REPLICATE THIS CONTRA-INDICATED USE, USING A LUNG STIMULATOR AND NMD EFFORT. UNDER THESE ABNORMAL USE CONDITIONS, THERE WAS EVIDENCE OF AUTO TRIGGERING, HOWEVER, THE REPORTED FAULT OF AUTOMATIC SHUTDOWN COULD NOT BE REPRODUCED. AS THE VPAP III IS NOT INTENDED FOR USE WITH RESTRICTIVE NMD PATIENTS, THE LIMITED RANGE OF TRIGGER SENSITIVITY AVAILABLE WOULD EXPLAIN AUTO TRIGGERING OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED FROM RESMED (B)(4) FOR A VPAPIII ST WHICH WAS REPORTEDLY "AUTO TRIGGERING AND SHUTTING OFF" WHILE BEING USED ON AN (B)(6) PATIENT WITH NEUROMUSCULAR DISEASE (NMD). THE PATIENT IS REPORTED TO HAVE BECOME CYANOTIC AND REQUIRED MANUAL VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP III ST - ASIA PACIFIC BZD RESMED LTD. 24106

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other 3M HOSE| THIRD PARTY HUMIDIFIER| RESPIRONICS EXHALATION PORT| TRACHEOTOMY TUBE