BEUDAMED
    FDA Adverse Event Death Summary report: N

    MVWS

    MDR report key: 1650997 · Received April 1, 2010

    Report

    Report Number
    1220063-2010-00007
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 11, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    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 MULTIVIEW WORKSTATION (MVWS) IN THE TELEMETRY AREA REBOOTED WHILE ACTIVELY MONITORING PATIENTS. IT WAS REPORTED THAT THE MVWS RETURNED TO THE NORMAL MONITORING SCREEN AFTER APPROXIMATELY 30 SECONDS AND DISPLAYED A "RECEIVER OFFLINE" MESSAGE. A DRAEGER TECHNICIAN WAS DISPATCHED AND REPORTED THAT WHEN HE ARRIVED THE MVWS WAS FUNCTIONING NORMALLY. IT WAS INITIALLY REPORTED TO THE DRAEGER MEDICAL AFTER HOURS CALL CENTER THAT A PATIENT HAD CODED DURING THIS EVENT AND EXPIRED. IN SUBSEQUENT CONVERSATIONS WITH HOSPITAL PERSONNEL, THEY REPORTED THAT THERE WAS NO PATIENT CODE. THE MVWS HAS REMAINED IN USE WITH NO FURTHER PROBLEMS REPORTED. (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MVWS PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) 5594465 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK