BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2941037 · Received January 31, 2013

    Report

    Report Number
    1720753-2013-01329
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 31, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PS3 POWER SUPPLY VOLTAGE WAS ADJUSTED, AND THE F1 AND F2 FUSES WERE TIGHTENED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INTERMITTENTLY THE MONITORS WOULD GO BLACK, RESULTING IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42396 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1