BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1900397 · Received October 26, 2010

    Report

    Report Number
    1720753-2010-03758
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    August 30, 2010
    Report Date
    October 26, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MONITOR AND PLUG WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM'S LEFT MONITOR FAILED TO OPERATE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1