BEUDAMED
    FDA Adverse Event Death Summary report: N

    VPAP WITH QUICKNAV AMERICAS

    MDR report key: 2803130 · Received October 19, 2012

    Report

    Report Number
    3004604967-2012-00041
    Event Type
    Death
    Date Received
    October 19, 2012
    Date of Event
    May 9, 2012
    Report Date
    October 19, 2012
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    PMA / PMN Number
    K033276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY EVAL OF THE RETURNED UNIT DID NOT SHOW ANY SIGNS OF DAMAGE OR DEGRADATION TO THE UNIT. THE UNIT CYCLED AND TRIGGERED FROM INSPIRATORY AND EXPIRATORY PRESSURES CORRECTLY AND AT SET TREATMENT PRESSURES. DEVICE MEMORY WAS DOWNLOADED AND PRELIMINARY REVIEW SHOWED THAT NO ANOMALIES WERE NOTED IN THE DATA. THE DEVICE WAS SENT TO THE DESIGN FACILITY IN (B)(4), FOR AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT RECEIVING THERAPY USING A RESMED VPAP PASSED AWAY. ON THE DAY OF THE EVENT, THE PT HAD BEEN IN THE LIVING ROOM ON THE VPAP UNIT. WHEN THE NURSE LEFT THE PT, THE PT WAS LOOKING NORMAL AND HER BLOOD PRESSURE AND HEART RATE WERE NORMAL. WHEN THE PT ASKED HER HUSBAND TO GO BACK TO BED, THE HUSBAND REMOVED THE PT FROM VPAP AND TOOK THE UNIT TO THE BEDROOM TO SET UP. ONCE IN BED, THE PT¿S BREATHING SEEMED LABORED POSSIBLY DUE TO THE EXERTION OF THE MOVE. THE HUSBAND PUT HER ON THE VPAP AND AFTER 5 MINUTES HE NOTICED IT STARTED TO NOT GIVE BREATHS. HE WAS GETTING THE BACK-UP UNIT WHEN SHE COLLAPSED. HE CALLED 911 AND THEY INSTRUCTED HIM TO START CPR. THE FIRE DEPARTMENT ARRIVED, TOOK OVER AND AT SOME POINT THEY GOT HER BACK. THE PT WAS TRANSPORTED TO HOSPITAL, WHERE SHE SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP WITH QUICKNAV AMERICAS MNS RESMED LTD. 24130

    Patients

    Seq Age Sex Outcome Treatment
    1 Death