BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESUSCITAIRE

    MDR report key: 1056164 · Received May 30, 2008

    Report

    Report Number
    2510954-2008-00005
    Event Type
    Other
    Date Received
    May 30, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 30, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    PMA / PMN Number
    k003335
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A DRAEGER TSR EVALUATED THE DEVICE, AND RETURNED THE HEATER ELEMENT. THE EVAL OF THE RETURNED HEATER ELEMENT AND THE CAUSE OF THE REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RESUSCITAIRE WARMER UNIT WAS IN "PRE-WARM" MODE. AT AN UNSPECIFIED TIME AFTER UNIT WAS PUT IN PRE-WARM MODE, THE STAFF OBSERVED SMOKE AND FLAME COMING FROM THE TOP OF THE WARMER MODULE COVER. THE FIRE DEPARTMENT WAS NOTIFIED, BUT THERE IS NO INDICATION THEY HAD TO INTERVENE. THERE WAS NO PT IN THE UNIT AT THE TIME, AND THERE WAS NO REPORT OF INJURY. THE BIOMED REMOVED TOP COVER OF THE WARMER MODULE AND OBSERVED ONE OF THE HEATER WIRES WAS DETACHED AND THERE WAS EVIDENCE OF RESIDUE INSIDE. THE FACILITY HAS REQUESTED A TSR TO EVALUATE THE FAILED UNIT ALONG WITH THEIR OTHER UNITS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other