BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3874332 · Received April 18, 2014

    Report

    Report Number
    1720753-2014-03416
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PS1 POWER SUPPLY WAS EVALUATED AND THE CALIBRATED TO THE OPTIMAL OPERATING VOLTAGE. THE GIB AND POWER MOTOR RELAY PCB ASSEMBLIES WERE ALSO EVALUATED AND REPLACED DURING THE SERVICE EVENT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR RESULTED IN THE SYSTEM BEING UNABLE TO CREATE FLUOROSCOPIC EXPOSURES. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237903 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1