BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 4063233 · Received August 8, 2014

    Report

    Report Number
    1720753-2014-06872
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 18, 2014
    Report Date
    August 8, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE PLUG WAS EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INTERCONNECT CABLE WAS FAULTY AND WOULD NOT CONNECT. THE FIELD ENGINEER RESPONDED THE SYSTEM WAS UNUSABLE BECAUSE THE CABLE COULD NOT BE CONNECTED AT ALL. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472985 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1