BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICS INFINITY CENTRAL STATION

    MDR report key: 2489064 · Received March 9, 2012

    Report

    Report Number
    1220063-2012-00017
    Event Type
    Death
    Date Received
    March 9, 2012
    Date of Event
    February 5, 2012
    Report Date
    February 9, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER REVIEWED THE INFO AND LOGS THAT WERE PROVIDED IN THE ORIGINAL COMPLAINT NOTIFICATION. THE CITED M300 WAS RETURNED TO DRAEGER FOR ANALYSIS. DRAEGER DETERMINED THAT THE M300 MONITOR AND THE CENTRAL STATION DID ALARM. AFTER REVIEWING THE LOGS AND TESTING THE M300, THE M300 SHUT DOWN DUE TO LOW BATTERY POWER AND THE ICS DID REPORT THE M300 AS OFFLINE. THE ICS LOGS CLEARLY SHOW THAT APPROX 1 MINUTE AFTER THE ICS REPORTED THE M300 OFFLINE, THE ICS ALARM SILENCE WAS PRESSED. THE M300 ALARM LOGS WERE NOT PROVIDED TO DRAEGER FOR ANALYSIS, AND THEREFORE, A MORE DETAILED ROOT CAUSE IS NOT POSSIBLE. DRAEGER DID DISCOVER A HARDWARE ISSUE WITH A COMPONENT ON THE M300, BUT THIS DID NOT CONTRIBUTE TO THE REPORTED ISSUE. NO ACTIONS ARE PLANNED BY DRAEGER AT THIS TIME FOR THE REPORTED INCIDENT. DRAEGER WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE M300 MONITOR DID NOT ALARM. IT WAS FURTHER REPORTED THAT THE CENTRAL STATION DID NOT ALARM FOR THE CITED MONITOR. ALL OTHER M300S DID ALARM AS EXPECTED AND WERE MONITORED ON THE STATION. THE CHECK ON 2/10/2012 OF THE CITED M300 WITH SIMULATOR REVEALED THAT THIS MONITOR TRANSFERRED ALARMS TO THE CENTRAL STATION. IT WAS REPORTED THAT THE NURSE FOUND THE PT IN A VERY BAD STATE OF HEALTH AT THE TIME OF THE INCIDENT. THE PT WAS REANIMATED. LATER THE PT DIED IN THE ICU. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICS INFINITY CENTRAL STATION PATIENT MONITOR DRT DRAEGER MEDICAL SYSTEMS, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NO