BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2251423 · Received September 9, 2011

    Report

    Report Number
    1720753-2011-21783
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 9, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS UNABLE TO PRODUCE FLUOROSCOPIC X-RAY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1