BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA

    MDR report key: 2200715 · Received August 4, 2011

    Report

    Report Number
    1220063-2011-00036
    Event Type
    Death
    Date Received
    August 4, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    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 PT MONITOR AND THE CENTRAL MONITOR DID NOT ALARM WHEN THE PT HAD ARRHYTHMIAS. THE PT LATER DIED DURING A PLANNED SURGERY, BUT IT WAS CONFIRMED THAT THE DEATH DURING THE SURGERY WAS NOT ASSOCIATED WITH THE INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS18597 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NO