BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAEGER ISOLETTE INFNT INCUBATOR

    MDR report key: 2820609 · Received October 31, 2012

    Report

    Report Number
    2510954-2012-00004
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 27, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K960980
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A DRAEGER SVC REP WAS REQUESTED BY THE FACILITY TO CHECK THE HUMIDITY MODULE FOR PROPER OPERATION AND THE SERVICE REPORT INDICATED THE MODULE MET MANUFACTURE SPECIFICATIONS AND FUNCTIONED AS INTENDED. IN THIS CASE THE USER HAND WAS BURNED FROM STEAM VAPORS WHEN ATTEMPTING TO REFILL THE RESERVOIR. THE INSTRUCTIONS FOR USE (IFU) SECTION "FILLING THE HUMIDITY RESERVOIR" PROVIDES THE USER WITH INSTRUCTIONS AND ILLUSTRATIONS REGARDING REFILLING THE RESERVOIR DURING USE. THE EVAPORATOR AND VAPOR PORT ARE LOCATED AT THE REAR OF THE RESERVOIR ASSEMBLY. REFILLING THE RESERVOIR DOES NOT REQUIRE COMPLETE REMOVAL FROM THE UNIT. BASED ON THIS, IT IS NOT KNOWN HOW THE USER WAS EXPOSED TO THE STEAM VAPORS WITHOUT COMPLETELY REMOVING THE RESERVOIR. A WARMING IN THE IFU STATES "THE EVAPORATOR CAN BE SUFFICIENTLY HOT TO CAUSE BURNS. AVOID REMOVING OR TOUCHING THE EVAPORATOR UNTIL THE HUMIDITY RESERVOIR HAS BEEN DISCONNECTED FROM THE INCUBATOR FOR AT LEAST 45 MINS. NONCOMPLIANCE MAY RESULT IN DEATH OR SERIOUS INJURY." THERE ARE ALSO THE INTERNATIONAL SYMBOLS FOR "CAUTION" AND "CAUTION: HOT SURFACE" EMBOSSED ON THE TOP SURFACE OF THE RESERVOIR ASSEMBLY AS A VISUAL WARNING TO THE USER. DRAEGER HAS MADE REPEATED ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE FACILITY IN REGARD TO THE EXTENT OF INJURY TO THE USER AND MORE DETAIL AS TO WHAT TRANSPIRED TO CAUSE THE INJURY TO HAVE OCCURRED. DRAEGER HAS NOT RECEIVED A RESPONSE TO THESE REQUESTS AFTER MAKING MULTIPLE ATTEMPTS. WITH THE LIMITED INFO PROVIDED NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    A NURSE WAS BURNED/SCALDED WHEN PULLING OUT THE RESERVOIR DRAWER TO FILL THE WATER RESERVOIR. IT WAS ALSO REPORTED THAT THERE WAS A RELEASE OF STEAM WHEN THE DRAWER WAS PULLING OUT. AS OF (B)(6) 2012, THE NURSE WAS STILL OUT OF WORK DUE TO THE INJURY. THE CUSTOMER REQUESTED TO HAVE A DRAEGER SERVICE ENGINEER COME TO THE HOSPITAL TO CHECK OUT THE ISOLETTE 8000 FOR PROPER FUNCTION. AFTER MULTIPLE ATTEMPTS, NO ADDITIONAL DETAILS COULD BE OBTAINED FROM THE HOSPITAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER ISOLETTE INFNT INCUBATOR INFANT INCUBATOR FMZ DRAEGER MEDICAL SYSTEMS, INC. ISOLETTE 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other