BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3843398 · Received March 14, 2014

    Report

    Report Number
    1720753-2014-02327
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUOROSCOPIC IMAGE WAS WHILE AND THAT THE KV WAS TRACKING TO MAXIMUM. THIS RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152424 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1