BEUDAMED
    FDA Adverse Event Death Summary report: N

    DELTA

    MDR report key: 2451029 · Received February 10, 2012

    Report

    Report Number
    1220063-2012-00014
    Event Type
    Death
    Date Received
    February 10, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 13, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEART RATE SLOWED DOWN AND THE NURSING STAFF DID NOT HEAR THE AUDIBLE ALARMS. THE PATIENT EXPIRED WHILE ATTACHED TO THE DEVICE. THE NURSES STATED THAT THEY COULD SEE THINGS FLASHING ON THE SCREEN, BUT THEY COULD NOT HEAR ANYTHING. THE BIOMED WAS ONSITE AND FOUND THAT THE ALARMS WERE SET TO 60 PERCENT AND THE AUDIBLE ALARM WAS INAUDIBLE. WHEN IT CHANGED TO 100 PERCENT, IT COULD BE HEARD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS24215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NO