BEUDAMED
    FDA Adverse Event Death Summary report: N

    VPAP III ST-A USA

    MDR report key: 2111668 · Received May 27, 2011

    Report

    Report Number
    3004604967-2011-00028
    Event Type
    Death
    Date Received
    May 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 27, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    PMA / PMN Number
    K051364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION THE DEATH WAS RELATED TO A DEVICE MALFUNCTION. THE PRELIMINARY EVALUATION OF THE RETURNED VPAP III ST-A DETERMINED THERE WAS NO FAULT WITH THE UNIT. EXTERNAL AND INTERNAL INSPECTION REVEALED NO SIGNS OF DAMAGE OR DEGRADATION.

    Description of Event or Problem · 1

    A PEDIATRIC PT WAS FOUND DECEASED WITH THE VPAP MACHINE STILL OPERATING. THE REPORTED CAUSE OF DEATH IS ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP III ST-A USA MNS RESMED LTD. 24116

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO Death PEDIATRIC MASK, OXYGEN AT 1 LITER PER MINUTE| BLEED INTO VPAP SYS