BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3060340 · Received April 11, 2013

    Report

    Report Number
    1720753-2013-04871
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED. HOWEVER, AS A PRECAUTIONARY MEASURE, THE ALL WORKSTATION CIRCUIT BOARDS, POWER SUPPLY CONNECTORS AND VIDEO LINES WERE RESEATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PERFORM FLUOROSCOPY. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156699 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1