BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 1070279 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-20513
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP WAS UNABLE TO DUPLICATE CUSTOMER PROBLEM. HE FOUND 5 VOLT SUPPLY IN TABLE AT 4.6 VOLTS. HE WAS UNABLE TO ADJUST POWER SUPPLY. THE REP ORDERED THE POWER SUPPLY THEN REMOVED AND REPLACED POWER SUPPLY. HE SET THE POWER SUPPLY FOR 5.1 VOLTS OUT. CHECKED SYSTEM FOR PROPER OPERATION. SYSTEM FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THIS SYSTEM LOCKED UP DURING CASE. NO PT INJURY. ALSO, CUSTOMER REPORTS TABLE WILL NOT BOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1