BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2030216 · Received March 7, 2011

    Report

    Report Number
    1720753-2011-01965
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 7, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE HAND SWITCH WAS REPLACED. THE SYSTEM WAS RETURNED AND IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 2800 SYSTEM WAS NOT BOOTING UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1