BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3821290 · Received April 16, 2014

    Report

    Report Number
    9680959-2014-00528
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 16, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE IPC 1000 WAS EVALUATED AND REPLACED. THE SYSTEM WAS RECONFIGURED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FE REPORTS THE DEVICE FREEZES UPON START-UP RESULTING IN NO-BOOT. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234226 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1