BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1071066 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22851
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM GIVE UPS FAIL ERROR. THE PRIMARY TRANSFORMER NEEDS TO BE ADJUSTED. THE REP INFORMED CUSTOMER THAT THIS SYSTEM CAN'T OPERATE IN OR 1,3,5 BECAUSE OF THE DROP IN WALL VOLTAGES FROM ROOM TO ROOM. INFORMED CUSTOMER THAT A ELECTRICIAN WOULD NEED TO BE CONTACTED TO FIX THE ISSUES IN ORDER TO OPERATE THIS SYSTEM IN THE ROOM. ADJUSTED TO 125 AND 6 TO MATCH ROOM VOLTAGE 122.1 SYSTEM IS NOW FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP DURING A CASE. THE PROBLEM OCCURRED WITH PT ON THE TABLE AND UNDER ANESTHESIA. THE SYSTEM WORKED AFTER REBOOT. THERE WAS NO PT INJURY.

    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