BEUDAMED
    FDA Adverse Event Death Summary report: N

    MVWS

    MDR report key: 2603399 · Received June 4, 2012

    Report

    Report Number
    1220063-2012-00041
    Event Type
    Death
    Date Received
    June 4, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 PT WAS BEING MONITORED BY A DRAEGER TRUST TELEMETRY PACK AND MULTIVIEW WORKSTATION. THE USER REPORTED THAT AN INITIAL R50 STRIP RECORDING FOR THE PT WAS RUN AFTER ADMISSION REPORTEDLY ON (B)(6) 2012. THE PT REPORTEDLY EXPIRED AT APPROX 9:00AM ON (B)(6) 2012. THE USER REPORTED THAT AFTER THE PT EXPIRED, A CHECK OF THE MVWS FULL DISCLOSURE DATABASE SHOWED THAT THERE WAS NO FULL DISCLOSURE DATA BEING COLLECTED UNTIL SEVERAL HOURS AFTER THE PT HAD BEEN ADMITTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MVWS PATIENT MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. 5594465 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death