BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800Q

    MDR report key: 3042500 · Received April 3, 2013

    Report

    Report Number
    1720753-2013-04586
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. ALL CIRCUIT BOARD CONNECTIONS WERE CLEANED AND RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE LEFT MONITOR IMAGE FROZE DURING SURGERY AND THE SYSTEM WAS DOWN. THIS RESULTED IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OR PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136278 9800Q FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1