BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3172198 · Received June 5, 2013

    Report

    Report Number
    1720753-2013-06782
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE SRAM MEMORY BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CHECKSUM ERROR MESSAGE. THIS ERROR MEANS THE SYSTEM DETECTED A FAILURE WHILE CHECKING ALL ASPECTS OF SOFTWARE AND HARDWARE DURING BOOTING UP. THIS MAY CAUSE THE SYSTEM TO NOT BOOT UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249179 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1