BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFANT INTENSIVE CARE SYSTEM

    MDR report key: 133769 · Received November 21, 1997

    Report

    Report Number
    2510954-1997-00013
    Event Type
    Other
    Date Received
    November 21, 1997
    Date of Event
    October 21, 1997
    Report Date
    October 22, 1997
    Manufacturer
    AIR- SHIELDS
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE NOTICED A SPARK AT THE TOP OF THE RADIANT WARMER AND WITNESSED A LITTLE "LIGHTNING BOLT" (ARC) ENTERING THE PTS CHEST AND EXITING THROUGH THE RIGHT HAND. THEN THE MATTRESS COVERING CAUGHT FIRE AND THE INFANT WAS REMOVED. THE INFANT RECEIVED MINOR BURNS ON THE CHEST AND FOUR FINGERS. NO CARDIAC ARREST OR OTHER PROBLEMS WITH THE PT WERE NOTED AND THE INFANT APPEARED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT INTENSIVE CARE SYSTEM INFANT RADIANT WARMER FMT AIR- SHIELDS 7810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other