BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESUSCITAIRE

    MDR report key: 755449 · Received August 28, 2006

    Report

    Report Number
    2510954-2006-00004
    Event Type
    Death
    Date Received
    August 28, 2006
    Date of Event
    July 18, 2006
    Report Date
    August 25, 2006
    Manufacturer
    DRAEGER MEDICAL INFANT CARE INC.
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESUSCITARE RADIANT WARMER IN QUESTION WAS MANUFACTURED AND SHIPPED IN 03/1995, AND THE MAINTENANCE ACTIVITIES ARE THE RESPONSIBILTIY OF THE HOSP. WE HAVE MADE SEVERAL ATTEMPTS TO INSPECT THE DEVICE, BUT THE USER FACILITY HAS NOT COOPERATED AND HAS YET TO LET US CHECK THE DEVICE. BASED ON THE DESCRIPTION OF THE EVENT, THERE IS NO INDICATION THAT THE DEVICE FAILED NOR HAS THE USER FACILITY INDICATED THE DEVICE HAS FAILED. WE WILL SUBMIT A FOLLOW-UP REPORT IF NEW INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A BABY WAS BEING RESUSCITATED WITH POSITIVE PRESSURE OXYGEN AND HAD BEEN ACTIVELY RESUSCITATED FOR APPROXIMATELY 20 MINUTES, WHEN THE PRESSURE DROPPED, DESPITE BEING PLUGGED INTO THE WALL OUTLET. RESUSCITATION WAS CONTINUED, USING A BAG AND MASK INTO WALL OXYGEN. THE BABY DIED SOMETIME AFTER BAGGING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUSCITAIRE RADIANT WARMER FMT DRAEGER MEDICAL INFANT CARE INC. RW81 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death