BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY MEGACARE

    MDR report key: 967281 · Received December 18, 2007

    Report

    Report Number
    1220063-2007-00044
    Event Type
    Malfunction
    Date Received
    December 18, 2007
    Date of Event
    October 11, 2007
    Report Date
    December 18, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT WHEN EDITING ECG WITH OUR INFINITY MEGACARE SOFTWARE APPLICATION, THE CORRECT TEXT IS NOT ALWAYS SHOWN ON THE PRINT OUT. THERE IS A DIFFERENCE FROM WHAT IS DISPLAYED ON THE SCREEN TO WHAT IS PRINTED OUT. THERE ARE DIFFERENT FAULTS THAT OCCUR, HOWEVER, THE NEW SIGNATURE/HEADLINE PRINTED TOGETHER WITH THE OLD TEXT IS A SERIOUS VARIANT. THIS INTERMITTENT FAULT HAS OCCURRED DURING THE LAST 18 MONTHS AND THE LAST OCCURRENCE WAS IN 2007. THE CUSTOMER IS CONCERNED THAT AN INCORRECT INTERPRETATION MAY OCCUR, BUT HAS REPORTED THAT THERE IS NO KNOWN CASE OF THIS OCCURRING. ALL WRONG PRINTOUTS HAVE BEEN DISCOVERED, AND THE STAFF CAREFULLY CONTROLS THE PRINTOUTS BY EXAMINING EVERY PRINTOUT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY MEGACARE INFINITY MEGACARE DATA MANAGEMENT SOFTWARE MHX DRAEGER MEDICAL SYSTEMS, INC. MS11750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR