BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3791725 · Received January 21, 2014

    Report

    Report Number
    1720753-2014-00733
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 21, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND DETERMINED THAT THE SRAM CARD IN THE C-ARM WILL REQUIRE REPLACEMENT, BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD 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
    50993 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1