BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2896240 · Received December 5, 2012

    Report

    Report Number
    9680959-2012-01694
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 5, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE LOW VOLTAGE POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM COMPLETELY LOST FUNCTIONALITY DURING A PM, DUE TO A DEFECTIVE POWER SUPPLY. THIS WOULD RESULT IN NO LIVE IMAGE BEING DISPLAYED. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1