BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK 3500

    MDR report key: 2241341 · Received August 17, 2011

    Report

    Report Number
    1720753-2011-12040
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    May 4, 2010
    Report Date
    August 17, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REPRESENTATIVER PERFORMED AN OVER THE PHONE EVALUATION. THE REPRESENTATIVE GUIDED THE CUSTOMER THROUGH A REBOOT OF THE SYSTEM. THE CUSTOMER REPORTS THAT THE SYSTEM OPERATES 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 (B)(6), 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 STOPPED WHILE BOOTING UP. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTATRAK 3500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) INSTATRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1