BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3013059 · Received March 1, 2013

    Report

    Report Number
    1720753-2013-03258
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REFORMATTED THE CINE DRIVE AND REPLACED THE SINGLE BOARD COMPUTER COIN BATTERY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM LOCKED DURING CINE OPERATIONS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90458 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1