BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3042612 · Received April 2, 2013

    Report

    Report Number
    1720753-2013-04511
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED AN INTERLOCK FAILURE ERROR MESSAGE. THIS ERROR MAY CAUSE THE SYSTEM TO SHUT DOWN UNCOMMANDED. 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
    133751 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1