BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1002755 · Received February 26, 2008

    Report

    Report Number
    1720753-2008-16397
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN INVESTIGATION. BASED ON INFO PROVIDED, THE FOLLOWING COMPONENT HAS BEEN ORDERED. SURGE SUPPRESSOR PCB. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENT IS REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFO IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2800 SYSTEM WOULD NOT BOOT UP OR POWER. ANOTHER SYSTEM USED TO FINISH THE CASE. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK