BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAK 2500

    MDR report key: 2100822 · Received May 12, 2011

    Report

    Report Number
    1720753-2011-07292
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 12, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP INSTRUCTED THE CUSTOMER OVER THE PHONE TO RELOAD THE PT SCAN, AND TO RECALIBRATE THE FIRST INSTRUMENT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY AN ERROR MESSAGE SAYING THAT THE VERIFICATION POINT WAS NOT CORRECT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRAK 2500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500

    Patients

    Seq Age Sex Outcome Treatment
    1