BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2960831 · Received January 30, 2013

    Report

    Report Number
    1720753-2013-01294
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE DISAPPEARING DURING EXAM. THIS ISSUE MAY CAUSE THE SYS TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. 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
    40829 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1