BEUDAMED
    FDA Adverse Event Death Summary report: N

    VPAP III ST-A QUICKNAV - ASIA PACIFIC

    MDR report key: 2245114 · Received September 9, 2011

    Report

    Report Number
    3004604967-2011-00046
    Event Type
    Death
    Date Received
    September 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    September 9, 2011
    Manufacturer
    RESMED LTD
    Product Code
    MNS
    PMA / PMN Number
    K033276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INSPECTION OF THE VPAP FLOW GENERATOR FOUND WATER INGRESS IN THE MOTOR ASSEMBLY AS WELL AS ON THE ELECTRICAL CIRCUITRY INCLUDING THE CONTROL CIRCUIT AND THE POWER SUPPLY CIRCUIT. THE RETURNED FLOW GENERATOR WAS ATTACHED TO THE F&P HUMIDIFIER UNIT, AND THE FIELD REPORT DESCRIBED THE DEVICE AND THE HUMIDIFIER FALLING OVER. THEREFORE IT IS CONCLUDED THAT WATER FROM THE F&P HUMIDIFIER IS THE MOST LIKELY CAUSE OF THE WATER INGRESS INTO THE VPAP FLOW GENERATOR. DATA DOWNLOADED FROM THE DEVICE INDICATED THERE WERE NO SYSTEM ERROR PRIOR TO THIS EVENT, AND THERE IS A RECORD OF A POWER FAIL ALARM OPERATING TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED BY A CORONER'S OFFICE IN (B)(6) THAT A PT BEING TREATED WITH A RESMED VPAP III ST-A QUICKNAV DEVICE DIED WHILE BEING TRANSPORTED WITHIN THE HOSPITAL. THE VPAP III ST-A DEVICE, WHICH HAD A WATER-FILLED HUMIDIFIER ATTACHED TO IT, FELL OVER WHILE THE PT WAS BEING TRANSPORTED. THE VPAP III ST-A DEVICE THEN STOPPED FUNCTIONING. THE PT'S HEALTH PRIOR TO THE INCIDENT AND DETAILS OF OTHER CO-MORBIDITIES ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP III ST-A QUICKNAV - ASIA PACIFIC MNS RESMED LTD 24139

    Patients

    Seq Age Sex Outcome Treatment
    1 Death FISHER & PAYKEL HUMIDIFIER