BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMMA XL

    MDR report key: 3760689 · Received April 10, 2014

    Report

    Report Number
    1220063-2014-00012
    Event Type
    Death
    Date Received
    April 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATION 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 PT DEATH OCCURRED BETWEEN 1:30 PM AND 2:00 PM. THE PT HAD A PACEMAKER, BUT THE PACEMAKER WAS NOT ACTIVATED ON THE MONITOR. THE FAMILY ALERTED THE SERVICE OF THE CARDIAC ARREST OF THE PT. THEY TRIED CARDIAC MESSAGE AROUND 2:00 PM, BUT WITHOUT SUCCESS. THE SERVICE INDICATES THAT THE MONITOR HAS NOT RUNG AND THAT ON THE DRAWING PEAKS ON THE ELECTROCARDIOGRAM CAN BE SEEN. THE ALARM OF SPO2 AND RESPIRATION RATE WAS DISABLED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216206 GAMMA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS18985 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death