BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 5142373 · Received October 10, 2015

    Report

    Report Number
    1720753-2015-04168
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    September 8, 2015
    Report Date
    March 31, 2016
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    OWB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RE-EVALUATION OF THE COMPLAINT AND THE ACCOMPANYING INVESTIGATION DETERMINED THERE WAS INSUFFICIENT INFORMATION TO CONCLUDE THAT THE FAILURE OF THE DEVICE WAS BASED SOLELY UPON THE AGE OF THE SYSTEM AND ITS ASSOCIATED COMPONENTS.

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SCSI BOARD AND THE SOFTWARE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THE REPORTED EVENT DETERMINED THAT THERE WAS NO DEVICE MALFUNCTION. THIS IS NOT A REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673849 8800 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1