BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAEGER ISOLETTE INCUBATOR

    MDR report key: 3095662 · Received April 26, 2013

    Report

    Report Number
    2510954-2013-00002
    Event Type
    Other
    Date Received
    April 26, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 26, 2013
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K960980
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO OBTAINED DURING OUR INVESTIGATION, THE C2000 INCUBATOR INVOLVED WAS NOT IDENTIFIED. ALL C2000 INCUBATORS AT THE FACILITY WERE TESTED FOR PROPER OPERATION AND FOUND TO FUNCTION AS INTENDED. THE ACTUAL DRAEGER DISPOSABLE PROBE INVOLVED IN THE INCIDENT WAS NOT AVAILABLE FOR EVALUATION. THE FACILITY PRACTICE IS TO REUSE DRAEGER DISPOSABLE PROBES UNTIL THEY FAIL TO FUNCTION AND ARE AWARE THAT DRAEGER DISPOSABLE PROBES ARE INTENDED FOR SINGLE USE ONLY. THE C2000 INCUBATOR WAS BEING USED IN "SKIN MODE" WHEN THE DRAEGER DISPOSABLE PROBE FAILURE OCCURRED. THE C2000 INCUBATOR WORKED AS INTENDED BY RESPONDING TO THE PROBE FAILURE WITH AN AUDIBLE AND VISUAL ALARM. IF THE USER DOES NOT RESPOND TO THIS ALARM CONDITION THE PT COMPARTMENT HEATER WILL BECOME DISABLED AND THE ALARM WILL CONTINUE UNTIL THE SITUATION IS CORRECTED. THE C2000 INCUBATOR WAS THEN SWITCHED TO "AIR MODE" AFTER THE PROBE FAILURE WAS REALIZED; HOWEVER, THE HEAD DOCTOR INDICATED THAT THE NURSES DID NOT ADJUST THE AIR TEMPERATURE SETTING AND THEREFORE, COULD NOT REGULATE THE TEMPERATURE APPROPRIATELY CAUSING THE PT TO BE UNDER HEATED. OUR DRAEGER REP HAS CONDUCTED IN SVC TRAINING WITH THE NURSES AND DOCTORS FOR PROPER OPERATION WHEN USING "AIR MODE" SETTING. THE USE OF THE DRAEGER DISPOSABLE, SINGLE USE PROBE IS NOT RECOMMENDED FOR REPEATED USAGE. THE LABELING AFFIXED TO THE DRAEGER DISPOSABLE PROBE CLEARLY STATES "DISPOSABLE" AND SINGLE PT USE."

    Description of Event or Problem · 1

    ON (B)(4) 2013 DRAEGER REC'D A COMPLAINT REGARDING A C2000 INCUBATOR. THE SERIAL NUMBER INFO WAS NOT PROVIDED. IT IS ALLEGED THAT WHILE OPERATING THE C2000 INCUBATOR IN "SKIN MODE" UTILIZING A DISPOSABLE PROBE ((B)(4)) THE PROBE FAILED. IT WAS REPORTED THAT THE PT DEVELOPED HYPOTHERMIA, WHICH ALLEGEDLY CONTRIBUTED TO THE PT'S DEATH. THE DATE OF THE INCIDENT IS (B)(6) 2013. REFERENCE MFR COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182194 DRAEGER ISOLETTE INCUBATOR INFANT INCUBATOR FMZ DRAEGER MEDICAL SYSTEMS, INC. C2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other