BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3921402 · Received May 21, 2014

    Report

    Report Number
    1720753-2014-04450
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 23, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY HARNESS WAS EVALUATED AND RESEATED. THE VOLTAGE PS1 POWER SUPPLY WAS EVALUATED AND ADJUSTED TO OPTIMUM OPERATING VOLTAGE. THE 3V BATTERY ON GIB WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM HAD A COMMUNICATION ERROR WHICH CAUSED THE SYSTEM TO LOCK UP. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303574 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1