BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1800069 · Received August 11, 2010

    Report

    Report Number
    1720753-2010-02440
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 21, 2010
    Report Date
    August 11, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RE-SEATED ALL CONNECTORS TO THE LEFT MONITOR. CHECKED INPUT VOLTAGE, OK. RE-SEATED CINE BRIDGE BOARD AND ALL ASSOCIATED CONNECTORS. CUSTOMER INDICATED THAT THESE SYMPTOMS HAVE NOT SHOWN FOR THIS PAST WEEK. COULD NOT DUPLICATE PROBLEM, BUT PERFORMED THESE CHECKS ANYWAY. VERIFIED PROPER OPERATION OF THE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INTERMITTENT BLANKING OF THE LEFT MONITOR AS WELL AS INTERMITTENT TROUBLE PLAYING CINE RUNS BACK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1