BEUDAMED
    FDA Adverse Event Other Summary report: N

    VPAP III ST-A TEIJIN

    MDR report key: 3044232 · Received April 2, 2013

    Report

    Report Number
    3004604967-2013-00010
    Event Type
    Other
    Date Received
    April 2, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    PMA / PMN Number
    K033276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER INVESTIGATION AT THE DESIGN HOUSE IN (B)(4). 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 DEVICE HAVE BEEN ASSESSED AND DO NOT WARRANT A RECOMMENDATION TO TAKE ANY IMMEDIATE CORRECTIVE OR CONTAINMENT ACTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PT (WITH DEMENTIA) CALLED A NURSE AND REPORTED THAT HER DEVICE, A RESMED VPAP III ST-A, HAD STOPPED. THE NURSE VISITED THE PT AT HOME AND FOUND THAT THE POWER SUPPLY UNIT APPEARED NOT TO HAVE BEEN CONNECTED. THE NURSE TRIED TO CONNECT THE POWER SUPPLY UNIT, WHICH SHOWED A 'SYSTEM ERROR' ALARM TRIGGER ON THE DEVICE, AND WAS UNABLE TO BEGIN VENTILATION. THE PT'S BREATHING DETERIORATED AND SHE WAS TAKEN TO THE HOSPITAL. IT WAS REPORTED THAT THE PT HAD A TRACHEOSTOMY PROCEDURE PERFORMED, AND IS CURRENTLY ON A MECHANICAL VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134412 VPAP III ST-A TEIJIN MNS RESMED LTD. 24122

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization OXYGEN