BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 3823188 · Received March 20, 2014

    Report

    Report Number
    1720753-2014-02568
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE CONTACTED THE CUSTOMER BY PHONE AND DIRECTED THEM IN REPAIRING THE SYSTEM. THE CUSTOMER REPLACED THE FUSE ON THE TABLE SENSOR PCB. THE SYSTEM OPERATES AS INTENDED AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT IF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167720 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1