BEUDAMED
    FDA Adverse Event Death Summary report: N

    M300

    MDR report key: 1624130 · Received March 4, 2010

    Report

    Report Number
    1220063-2010-00003
    Event Type
    Death
    Date Received
    March 4, 2010
    Date of Event
    February 13, 2010
    Report Date
    February 15, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    K061379
    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 A PATIENT WAS IN ASYSTOLE FOR 4 MINUTES AND DURING THAT PERIOD, NO ALARM WAS TRIGGERED. IT WAS REPORTED THAT THE PATIENT DIED. (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M300 PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) UNK 5750451774

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death