BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTIVIEW WORKSTATION

    MDR report key: 2570807 · Received May 1, 2012

    Report

    Report Number
    1220063-2012-00039
    Event Type
    Death
    Date Received
    May 1, 2012
    Date of Event
    April 22, 2012
    Report Date
    April 25, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    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 ON (B)(6) 2012, AT APPROXIMATELY 07:30, THE PT REPEATEDLY SUFFERED AN ASYSTOLY FOR A SHORT TIME. THE PT WAS RESUSCITATED AFTERWARDS AND DIED APPROXIMATELY 1.5 HRS LATER. THE PT WAS CONNECTED TO THE UHF_TELEMETRY EMITTER1 AND HAD A HEART PACEMAKER. ACCORDING TO THE STATEMENT OF THE DEPT, NEITHER THE MULTIVIEW WORKSTATION (MVWS) NOR THE NURSE CALL THAT WAS ALSO CONNECTED GENERATED AN ALARM. DURING INSPECTION OF THE EMITTER TELE1, (B)(6), AND THE MVWS (ICU), A MALFUNCTION COULD NOT BE FOUND. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVIEW WORKSTATION PATIENT MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. 7488294 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NO