BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 3014233 · Received March 6, 2013

    Report

    Report Number
    9680959-2013-00492
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 6, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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 SCREEN WAS GOING BLANK DURING PROCEDURES. THIS ISSUE WILL CAUSE THE SYSTEM 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
    96586 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1