BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA XL

    MDR report key: 2247948 · Received September 8, 2011

    Report

    Report Number
    1220063-2011-00045
    Event Type
    Death
    Date Received
    September 8, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 19, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITOR DID NOT RECOGNIZE THAT ONLY PACEMAKER PULSES WERE DISPLAYED, BUT NO PHYSIOLOGICAL HEART ACTIVITY WAS PRESENT. IT WAS FURTHER REPORTED THAT TESTING ON (B)(6) 2011 AT 12:30 H USING AN ECG SIMULATOR RESULTED IN FAULTLESS FUNCTION OF THE MONITOR. ALL ALARMS WERE CORRECTLY DISPLAYED AND POSTED. IT WAS REPORTED THAT THE PT DIED. HOWEVER, DEATH WAS ALREADY IN PROGRESS AND EXPECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS18596 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO