BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1021738 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-19712
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SVC REP RESTRAPPED TRANSFORMER SO THAT OUTPUT AT TRANSFORMER WAS 122V AC. FACILITY WALL VOLTAGE IS AT 111V SO THE TRANSFORMER WAS STRAPPED FOR 6 AND 113 ON THE INPUT OF THE TRANSFORMER. UNABLE TO DUPLICATE SYSTEM LOCK UP. MACHINE FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN UNK PROCEDURE THE SYSTEM COLLIMATOR COLLIMATED IN SOMEWHAT, THEN SYSTEM LOCKED UP. THEY WERE UNABLE TO PUT THE SYSTEM INTO MAG MODE OR SEND IMAGES TO PACS. IT WAS ALSO SLOW TO SAVE IMAGES. SYSTEM WOULD STILL TAKE FLUORO IMAGES, SO CASE WAS COMPLETED WITHOUT REBOOTING SYSTEM. AFTER SYSTEM REBOOT ALL NORMAL FUNCTIONS RETURNED. FOUND IN ERROR LOGS THAT SYSTEM LOST COMMUNICATION WITH FLUORO FUNCTIONS PCB CAUSING SYSTEM TO LOCK UP. ALSO FOUND THAT SYSTEM POWER WAS AT 115V AT OUTPUT OF TRANSFORMER. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1