BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSAT POWER SUPPLY

    MDR report key: 2190924 · Received July 19, 2011

    Report

    Report Number
    3008729547-2011-00004
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    DPZ
    PMA / PMN Number
    K040831
    Removal / Correction Number
    9610105-2/9/2011-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE POWER SUPPLY HAS NOT BEEN RETURNED FOR FURTHER EVAL, HOWEVER, THERE IS A KNOWN PROBLEM WITH THIS SERIES OF POWER SUPPLIES THAT INCLUDES A FAILURE MODE SIMILAR TO THAT REPORTED. THE EVAL OF OTHER INCIDENTS THAT DISPLAYED THIS PROBLEM IS THE FOLLOWING: 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 12/20/2010, AND IS IMPLEMENTING A FIELD ACTION FOR AFFECTED UNITS. GE HEALTHCARE HAS REPORTED THE ISSUE TO FDA PER 21 CFR PART 806.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRUSAT EXTERNAL POWER SUPPLY OVERHEATED AND THE EXTERNAL ENCLOSURE SHOWED EVIDENCE OF MELTING. THE AFFECTED DEVICE WAS REMOVED FROM SERVICE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUSAT POWER SUPPLY POWER SUPPLY DPZ CRITIKON DE MEXICO S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1