BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPAP III ST-A NORDIC

    MDR report key: 1976383 · Received January 28, 2011

    Report

    Report Number
    3004604967-2011-00007
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    February 11, 2009
    Report Date
    January 28, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    PMA / PMN Number
    K033276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL DETERMINED THAT MOST LIKELY THE PATIENT SETTINGS WERE LOST WHEN THE DEVICE WAS SERVICED, TWO MONTHS PRIOR TO THE INCIDENT. A REVIEW OF THE DEVICE SETTINGS FOUND A MIXTURE OF FACTORY DEFAULT AND CUSTOM SETTINGS. THEY WERE NOT SETTINGS SET BY THE SERVICE SOFTWARE AS PART OF CALIBRATION AND CALIBRATION TEST PROCEDURES. THEREFORE, IT WAS NOT POSSIBLE TO DETERMINE WHEN SETTINGS WERE CHANGED OR CONFIRM THE HOSPITALS REPORT THAT THE PATIENT SETTINGS WERE LOST. THE DEVICE WAS EXAMINED AFTER BEING RETURNED TO RESMED LTD AND PASSED FUNCTIONAL TESTING. NO DEVICE FAULT WAS FOUND. THE SERVICE PROCEDURE FOR THE VPAPIII ST-A REQUIRES THE PATIENT SETTINGS TO BE SAVED, AS THE TEST AND CALIBRATION PROCESS WILL OVERWRITE THE DEVICE SETTINGS. CAUTIONS RELATING TO THIS ARE CLEARLY STATED IN THE SERVICE MANUAL AND SERVICE TECHNICIANS ARE TRAINED TO THIS STANDARD SERVICING PROCEDURE.

    Description of Event or Problem · 1

    A PATIENT WAS REPORTED TO HAVE SUFFERED ACUTE RESPIRATORY FAILURE WHILE USING A VPAP III ST-A DEVICE IN HOSPITAL. THE PATIENT SETTINGS ON THE DEVICE HAD BEEN LOST TWO MONTHS PREVIOUSLY, POSSIBLY WHEN THE DEVICE WAS SERVICED BY HOSPITAL TECHNICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP III ST-A NORDIC MNS RESMED LTD. 24125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other