BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAK

    MDR report key: 2241343 · Received August 17, 2011

    Report

    Report Number
    1720753-2011-11060
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    February 9, 2010
    Report Date
    August 17, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE CONDUCTED A PHONE EVALUATION. THE CUSTOMER REBOOTED THE SYSTEM AFTER THE UPS WAS DONE CYCLING DOWN. THE SYSTEM WAS REPORTED OPERTATING AS INTENDED. DURING A RETROSPECTIVE REVIEW THIS EVENT WAS DETERMINED TO BE REPORTABLE. IT WAS INCLUDED AS PART OF A RETROSPECTIVE SUMMARY REPORT (RSR) REQUEST TO FDA ON APRIL 26, 2011 (B)(4). FDA REQUESTED THIS EVENT TO BE REMOVED FROM THE RSR REQUEST AND FILED VIA 3500A.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD LOCK UP. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1