BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2994170 · Received February 13, 2013

    Report

    Report Number
    1720753-2013-01732
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 13, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE CINE BRIDGE PCB WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE CINE RUNS WERE PLAYED BACK, THE IMAGES WERE BLANK AND BLACK, RESULTING IN A LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. THERE IS REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64295 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1