BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 962290 · Received December 12, 2007

    Report

    Report Number
    9617766-2007-00344
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Date of Event
    November 17, 2007
    Report Date
    December 11, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP ERASED THE FFD, SRV AND MC FLASH, RELOADED SYSTEM SOFTWARE, THEN RESTORED ALL CAL FILES. CHECKED THE MF POWER SUPPLIES AND FOUND THESE IN SPECIFICATION. ORDERED PARTS. CALL WAS LATER CANCELED BY THE CUSTOMER, AND PROBLEMS WILL BE RESOLVED BY INHOUSE SERVICE GROUP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SYSTEM WILL NOT BOOT. AFTER RELOADING THE CAL FILES AND SEVERAL REBOOTS, THE SYSTEM CONTINUES TO MAKE XRAYS BY ITSELF, WHEN TAKING AN EXPOSURE. THE SYSTEM BOOTUP PROCESS HANG-UP AT APPROXIMATELY 10 ARROWS, THEN THE MF DISPLAY GOES BLANK. THE WS HARD DRIVE INTERMITTENTLY WILL NOT BOOT TO THE TRACK/SECTOR TEST. DETERMINED THE WS HARD DRIVE WAS DEFECTIVE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR