BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SC7000

    MDR report key: 1882756 · Received October 22, 2010

    Report

    Report Number
    1220063-2010-00061
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    May 14, 2009
    Report Date
    May 18, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT SHOULD BE NOTED THAT THE LOGS SENT BY THE COMPLAINANT ARE FROM TWO DIFFERENT PT MONITORS. FOR THE SECOND MONITOR, (B)(4), THE DIAGNOSTIC LOGS WE RECEIVED WERE OVERWRITTEN. DESPITE OUR BEST EFFORTS, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED DUE TO MISSING INFO. NO CORRECTIVE ACTIONS ARE PLANNED BY THE MANUFACTURER AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS OF THIS CONDITION.

    Description of Event or Problem · 1

    REFERENCE: MDR 1220063-2009-00015. PER TELEPHONE COMMUNICATION WITH DRAEGER MEDICAL REGARDING THE SUBMITTAL OF ADDITIONAL MDRS FOR EACH SERIAL NUMBER LISTED ON THE INITIAL MDR SUBMITTED, DRAEGER IS SUBMITTING THIS REPORT. IT WAS REPORTED THAT THERE WAS A TEMPORARY LOSS OF THE CARDIO-RESPIRATORY DATA OF PTS WHO ARE CONNECTED TO THE MONITOR; THEN SPONTANEOUS "RE-START". NO PT INJURY WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC7000 PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO