BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSAT POWER SUPPLY

    MDR report key: 2020436 · Received February 8, 2011

    Report

    Report Number
    9613557-2011-00003
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 23, 2010
    Report Date
    February 8, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DPZ
    PMA / PMN Number
    K040831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY WAS RETURNED FOR INVESTIGATION AND THE REPORTED COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS IDENTIFIED TO BE A DESIGN PROBLEM WITH THE POWER SUPPLY, PROVIDING INADEQUATE PROTECTION AGAINST OVERHEATING OF ELECTRICAL COMPONENTS (DUE TO AC MAIN SUPPLY FLUCTUATION, COMPONENT FAILURE OR A SHORT IN POWER CORD / DEVICE). GE HEALTHCARE STOPPED SHIPPING THE AFFECTED UNITS ON (B)(4) 2010, AND PLANS TO IMPLEMENT A FIELD ACTION FOR AFFECTED UNITS. GE HEALTHCARE WILL BE REPORTING THE ISSUE TO FDA PER 21 CFR PART 806.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRUSAT EXTERNAL POWER SUPPLY STOPPED WORKING AND WAS WARM TO THE TOUCH. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUSAT POWER SUPPLY POWER SUPPLY DPZ GE HEALTHCARE GTM21089-1512-T3

    Patients

    Seq Age Sex Outcome Treatment
    1