BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUSCITAIRE

    MDR report key: 1576268 · Received December 22, 2009

    Report

    Report Number
    2510954-2009-00004
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    May 28, 2009
    Report Date
    December 22, 2009
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROLLER AND THE QUARTZ HEATER ELEMENTS WERE RETURNED FOR INVESTIGATION. THE REPLACEMENT HEATER WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE HEATER WAS INSPECTED AND TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE CONTROLLER WAS RECEIVED COVERED IN DUST AND APPEARS TO HAVE NOT BEEN PROPERLY MAINTAINED. UPON DISASSEMBLY OF THE CONTROLLER IT WAS CONFIRMED THAT THIS WAS THE ORIGINAL BOARD WHICH WAS PRODUCED IN OCTOBER OF 2000 AND THE DAMAGE WAS FOUND TO BE ISOLATED TO THE POWER BOARD IN THE AREA OF THE RELAYS. THE SOLID STATE RELAYS AND SAFETY RELAY WERE REMOVED FROM THE BOARD AND INDIVIDUALLY TESTED. THE SOLID STATE RELAYS AND THE SAFETY RELAY WERE FOUND TO BE OPERATIONAL. FURTHER INVESTIGATION REVEALED THAT THE FAILURE WAS ISOLATED TO THE AC HOT SIGNAL POWER BOARD TRACE FROM CONNECTOR J6 TO THE SAFETY RELAY K1, PINS 6 AND 7. THE FAILURE WAS CAUSED BY A HIGH CONTACT RESISTANCE BETWEEN THE PLACED THRU HOLE AND THE TRACE. THE HIGH CONTACT RESISTANCE WAS CAUSED BY A DEGRADATION OF THE PLANTED THRU HOLE OVER TIME.

    Description of Event or Problem · 1

    THE BIOMED STATED THAT SHE REPLACED THE QUARTZ HEATING ELEMENT WHILE THE WARMER WAS LOCATED IN THE NURSERY. AFTER REPLACING THE QUARTZ HEATING ELEMENT, SHE POWERED UP THE WARMER, SHE HEARD A BUZZING SOUND AND THEN IMMEDIATELY SAW SMOKE AND FLAME COMING FROM THE TOP OF THE COLUMN AND IN THE AREA OF THE CONTROLLER. SHE IMMEDIATELY PULLED THE AC PLUG. THE BIOMED STATED THAT THE FLAME AND SMOKE LASTED ABOUT 7 SECONDS. ONLY ONE INFANT WAS IN THE NURSERY AT THE TIME AND WAS BEING HELD BY A STUDENT NURSE. AT THE TIME OF THE EVENT, THE STUDENT NURSE IMMEDIATELY EXITED THE ROOM WITH THE INFANT. NO INJURY WAS REPORTED. (B) (4).

    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 NA