BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3172040 · Received June 10, 2013

    Report

    Report Number
    1720753-2013-06884
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE WAS REPLACED, THE SYSTEM SOFTWARE WAS RELOADED, AND THE CINE DRIVE WAS REFORMATTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP DURING A PROCEDURE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261590 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1