BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIVIEW WORKSTATION

    MDR report key: 858826 · Received June 1, 2007

    Report

    Report Number
    1220063-2007-00007
    Event Type
    Injury
    Date Received
    June 1, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 31, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF ELECTRONIC DEVICE LOGS AND RELEVANT PT DATA. THIS CASE INVESTIGATED BY REVIEWING THE DEVICE LOGS AND PT EVENT INFO AT THE USER SITE BY A CLINICAL REP. NO EVIDENCE OF A DEVICE MALFUNCTION OR USER-ERROR CAN BE FOUND IN THE MATERIALS SUPPLIED. WE CONCLUDE THAT THE MONITOR WAS FUNCTIONING AS DESIGNED BY ANNUNCIATING 2 LIFE-THREATENING ALARMS WITHIN 30 SECONDS OF THE EVENT, ALERTING STAFF TO THE PRESENCE OF A CLINICAL CONDITION.

    Description of Event or Problem · 1

    IN 2007, RECEIVED A NOTIFICATION THAT A CUSTOMER SITE REPORTED THAT OUR MULTIVIEW WORKSTATION HAS A DELAY IN ALARMING FOR A V-FIB EVENT AND THE CUSTOMER WANTS TO KNOW AN EXPLANATION AS TO THE ROOT CAUSE FOR THE DELAY IN ALARMING. AFTER THE ORIGINAL INCIDENT NOTIFICATION A CONFERENCE CALL WAS HELD ON 5/15/2007 WITH REPRESENTATIVES FROM TECHNICAL SUPPORT SVC. IN ADDITION, A CLINICAL ENGINEER WAS AT THE CUSTOMER SITE ON 5/15/2007 TO INVESTIGATE THE REPORTED INCIDENT. SHORTLY THEREAFTER, WE WERE INFORMED BY OUR LOCAL FIELD OFFICE THAT THE CUSTOMER INDICATED THAT THE INVOLVED PT HAD SUFFERED AN INJURY, (HYPOXIC BRAIN INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVIEW WORKSTATION CENTAL STATION MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. 7488302 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other