BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES DC POWER SUPPLY

    MDR report key: 2592059 · Received May 25, 2012

    Report

    Report Number
    2518422-2012-00617
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    April 1, 2012
    Report Date
    April 25, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR RECEIVED THE POWER SUPPLY AND CONFIRMED THERE WERE THERMAL DAMAGES TO THE POWER SUPPLY AND AC POWER CORD, LEADING TO AN EXPOSED AC CONDUCTOR. UPON COMPLETION OF THE INVESTIGATION A F/U REPORT WILL BE FILED. POWER SUPPLY IS USED WITH REMSTAR PLUS M-SERIES, K010263, K052110.

    Description of Event or Problem · 1

    THE MFR'S SERVICE CENTER REPORTED THAT A POWER SUPPLY AND POWER CORD RETURNED BY A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) WERE THERMALLY DAMAGED. THERE HAD BEEN NO REPORT OF INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-SERIES DC POWER SUPPLY NONE BZD RESPIRONICS, INC. 1015642

    Patients

    Seq Age Sex Outcome Treatment
    1