BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAEGER ISOLETTE INFANT INCUBATOR

    MDR report key: 2554673 · Received April 27, 2012

    Report

    Report Number
    2510954-2012-00002
    Event Type
    Injury
    Date Received
    April 27, 2012
    Date of Event
    March 17, 2012
    Report Date
    March 29, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K960980
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER COMPLETED THE INVESTIGATION FOR THIS REPORT. BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THE DEVICE FAILED TO FUNCTION AS INTENDED. IN THIS CASE THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU) IN WHICH A WARMING 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 MINUTES. 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. IN THIS CASE THE USER REMOVED THE HUMIDITY RESERVOIR ASSEMBLY AND IMMEDIATELY ATTEMPTED TO EMPTY THE CONTENTS BEFORE ALLOWING THE NECESSARY COOL DOWN AS INSTRUCTED IN THE IFU. THE BIOMEDICAL ENGINEER NOTED THE USER INVOLVED IN THE INCIDENT HAD ATTENDED IN-SERVICE TRAINING ON THE DEVICE PRIOR TO THE INCIDENT. THE INJURY NOTED WAS CONFINED TO THE LOWER ARM WITH REDDENING OF THE SKIN WHICH DEVELOPED BLISTERS. THE USER HAD TREATMENT FOR THE BLISTERS WHICH HAVE SINCE DISAPPEARED AND WAS CLEARED BY THE OCCUPATIONAL HEALTH PHYSICIAN TO RETURN TO WORK WITH NO RESTRICTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PATIENT WAS RECEIVING HUMIDITY THERAPY FROM AN I8000 AND THE PHYSICIAN ORDERED IT DISCONTINUED. THE 2 RN'S FELT IT WAS IMPORTANT TO EMPTY THE RESERVOIR IN THE EVENT THEY WOULD FORGET TO DO SO. THE RN REMOVED THE RESERVOIR FROM THE I8000, WALKED TO THE SINK, TURNED THE CHAMBER OVER AND HOT WATER CAME OUT FROM SEVERAL AREAS OF THE RESERVOIR, SPEWING IN THE DIRECTION OF HER LEFT ARM, HITTING HER LOWER ARM. THE AREA WAS RED, DEVELOPED BLISTERS AND WAS PAINFUL. THE RN WAS SEEN IN THE EMERGENCY CENTER IMMEDIATELY AFTER THE EVENT. SILVADENE CREAM WAS APPLIED AND A DRESSING WAS PLACED OVER THE AREA. THE RN WAS INFORMED TO RETURN TO HER WORK DUTIES. AS OF (B)(6) 2012, THE AREA IS HEALING, WITH NO OPEN AREAS, BLISTERS HAVE DISAPPEARED AND THERE IS NO PAIN. THE RN SAW THE OCCUPATIONAL HEALTH PHYSICIAN AND WAS CLEARED TO RETURN TO WORK WITHOUT RESTRICTIONS. HER FIRST DAY BACK WAS (B)(6) 2012. SHE MISSED 1 DAY OF WORK ON (B)(6) 2012. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other