BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3171983 · Received June 10, 2013

    Report

    Report Number
    1720753-2013-06919
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT MONITOR DIED. THIS COULD CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE LOSS OF THE LIVE FLUOROSCOPIC IMAGE. 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
    261494 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1