BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VPAP III ST-A USA

    MDR report key: 1518161 · Received October 26, 2009

    Report

    Report Number
    3004604967-2009-00022
    Event Type
    Malfunction
    Date Received
    October 26, 2009
    Date of Event
    September 23, 2009
    Report Date
    October 23, 2009
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    PMA / PMN Number
    K033276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02-OCT-2009, THE COMPLAINT UNIT WAS RECEIVED AT RESMED CORP LOCATED IN (B) (4). PRELIMINARY INVESTIGATION INDICATES THAT THE POWER CORD PLUG WAS DAMAGED AS A RESULT OF ARCING. DETAILED INVESTIGATION IS UNDERWAY AT THE DESIGN AUTHORITY (RESMED LTD, (B) (4)).

    Description of Event or Problem · 1

    A DME REPORTED THAT A RESMED VPAP UNIT WAS ARCING AT THE POWER CORD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1