BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2090596 · Received April 26, 2011

    Report

    Report Number
    1720753-2011-06572
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE EXPOSED WIRES FROM A CABLE ON THE 9900 SYSTEM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1