BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1040754 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21397
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP ASKED TO OBSERVE THE BIOMED TROUBLESHOOTING. SYSTEM DID NOT DUPLICATE MALFUNCTION. BIOMED CONTINUING TO TROUBLESHOOT UPON THE SERVICE REP'S DEPARTURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TABLE TILTED INSTEAD OF LIFTING. A PT WAS INVOLVED BUT NOT INJURED. REBOOTING RESET SYSTEM CASE WAS COMPLETED WITH NO FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1