BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESUSCITAIRE INFANT RADIANT WARMER

    MDR report key: 1521813 · Received November 3, 2009

    Report

    Report Number
    2510954-2009-00008
    Event Type
    Death
    Date Received
    November 3, 2009
    Date of Event
    September 24, 2009
    Report Date
    November 3, 2009
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    PMA / PMN Number
    K003335
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE GAS CONFIGURATION AT THE USER FACILITY UTILIZES ONE GAS SOURCE TO BE WALL (O2) AND THE OTHER TO BE RESERVE TANK SOURCE (AIR). A DRAEGER SERVICE REP WAS DISPATCHED AND OBSERVED A THIRD PARTY DISPOSABLE PT CIRCUIT WAS USED INSTEAD OF THE MANUFACTURER PART. THE BLENDER ALARMED AS DESIGNED TO INDICATE LOSS OF GAS PRESSURE SOURCE. THIS OCCURS WHEN THE PRESSURE DIFFERENTIAL BETWEEN THE GAS SOURCES EXCEEDS 207 KPA (30 PSI) +/- 14 KPA (2 PSI). THE INSTRUCTIONS FOR USE INCLUDES A WARNING STATING: "IF EITHER THE AIR OR OXYGEN GAS SOURCE IS REDUCED, CREATING A PRESSURE DIFFERENTIAL OF 207 KPA (30 PSI), THE BLENDER ALARM SOUNDS. THIS CONDITION CAN ALTER THE FIO2 AND FLOW OUTPUT FROM THE MICROBLENDER. INFANT INJURY COULD OCCUR." THE USER FACILITY'S RESERVE TANK SOURCE (AIR) CAPACITY DEPLETED, THEREBY CAUSING THE ALARM CONDITION. DEVICE OPERATION WAS CHECKED BY A DRAEGER SERVICE REP AND FOUND TO BE FUNCTIONAL. BASED ON THE INFO SUPPLIED TO DATE, THERE IS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IN THE PROCESS OF A DIFFICULT RESUSCITATION OF PT, THE USER FACILITY'S RESERVE TANK (AIR) CAPACITY RAN OUT CAUSING INFLATION PRESSURE TO DROP TO A LEVEL WHERE INSUFFICIENT PRESSURE WAS AVAILABLE TO CONTINUE RESUSCITATION. THE BLENDER ALARMED TO ALERT THE USER TO THE CONDITION; HOWEVER, THEY WERE UNABLE TO CORRECT THE SITUATION AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUSCITAIRE INFANT RADIANT WARMER INFANT RADIANT WARMER FMT DRAGER MEDICAL SYSTEMS, INC. (PNC) RW82 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death