BEUDAMED
    FDA Adverse Event Injury Summary report: N

    READY HEAT INFANT WARMING MATTRESS

    MDR report key: 9106084 · Received September 23, 2019

    Report

    Report Number
    MW5089968
    Event Type
    Injury
    Date Received
    September 23, 2019
    Date of Event
    September 12, 2019
    Report Date
    September 19, 2019
    Manufacturer
    TECH TRADE LLC
    Product Code
    KME
    UDI-DI
    00741459697167
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEWBORN INFANT TRANSPORTED TO HOSP BY EMERGENCY MEDICAL SERVICES FOLLOWING AN UNEXPECTED HOME DELIVERY OF A (B)(6) GESTATION BABY. THE BABY WAS PLACED IN AN AMBULANCE CHILD RESTRAINT WITH THE WARMING MATTRESS INSIDE THE ACR WITH A PAPER BLANKET FROM THE OB PACK BETWEEN THE BABY AND THE WARMING MATTRESS. THE BABY WAS THEN SWADDLED AROUND WITH BLANKETS. THE PARAMEDIC PLACED THE BABY ON BLOW BY OXYGEN. THE PAPER BLANKET HAD SHIFTED DURING TRANSPORT RESULTING IN THE WARMING MATTRESS BEING AGAINST THE INFANT'S BARE SKIN AND RESULTED IN 9% BURN TO COCCYX AND SHOULDER. THIS IS THE SECOND TIME IN THIS STATE THAT AN INFANT BEING TRANSPORTED BY EMS HAS RECEIVED A BURN FROM A READY HEAT MATTRESS. THE FIRST TIME THIS OCCURRED, ADD'L EDUCATION WAS PROVIDED TO ALL EMS AGENCIES AND BRIGHT ORANGE LABELS WERE PROVIDED TO WARN AGAINST USE WITH OXYGEN. THIS TIME, AS THE STATE AGENCY THAT PROVIDED THE READY HEAT MATTRESSES TO ALL EMS VEHICLES, AN ORDER WAS ISSUED FROM THE OFFICE TO REMOVE THE READY HEAT MATTRESS FROM ALL EMS VEHICLES AND NOT USE THEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901331 READY HEAT INFANT WARMING MATTRESS BEDDING, DISPOSABLE, MEDICAL KME TECH TRADE LLC PART# S2RHIM UNK 00741459697167

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other