BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3020907 · Received March 18, 2013

    Report

    Report Number
    1720753-2013-03880
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FUSE WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM HAD A LOST OF POWER. THIS SITUATION IS A POTENTIAL HAZARD BECAUSE AN UNCOMMANDED SYSTEM SHUT DOWN OCCURRED DURING A PT PROCEDURE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112893 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1