BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK 3500

    MDR report key: 2062088 · Received April 6, 2011

    Report

    Report Number
    1720753-2011-03314
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ACCURACY OF THE INSTRUMENT WAS OFF BY TWO INCHES ON THE INSTATRAK 3500 SYSTEM. NO PT INJURY WAS 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