BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9000

    MDR report key: 2935273 · Received January 14, 2013

    Report

    Report Number
    1720753-2013-00622
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE MONITOR POWER SUPPLY NEEDS TO BE REPLACED. THE CUSTOMER CANCELLED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM LEFT MONITOR WOULD NOT DISPLAY. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21212 9000 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9000

    Patients

    Seq Age Sex Outcome Treatment
    1