BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VPAP III ST-A QUICKNAV

    MDR report key: 2844710 · Received November 1, 2012

    Report

    Report Number
    3004604967-2012-00044
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 1, 2012
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    PMA / PMN Number
    K033276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER INVESTIGATION AT RESMED LTD. INVESTIGATION METHODS, RESULTS AND CONCLUSIONS ARE NOT FINALIZED AT THIS STAGE. THE SAFETY RISK AND OCCURRENCE RATE FOR THIS FAILURE MODE IN THE VPAP III ST-A QUICKNAV DEVICE HAVE BEEN ASSESSED AND DO NOT WARRANT A RECOMMENDATION TO TAKE ANY IMMEDIATE CORRECTIVE OR CONTAINMENT ACTIONS. THERE IS NO INFO REGARDING THE PT OUTCOME FROM THIS EVENT. IT IS ALSO UNCLEAR AS TO THE STATUS OF THE PT'S HEALTH OR CO-MORBIDITIES PRIOR TO THE INCIDENT. VERY LITTLE INFO IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT TREATMENT STOPPED WHILE A CRITICAL CARE PT WAS ON A RESMED VPAP III ST-A QUICKNAV DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1