BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSWARMER

    MDR report key: 3022962 · Received March 21, 2013

    Report

    Report Number
    1216677-2013-00007
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 20, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT ID WAS CONFIRMED AND AN IMMEDIATE REVIEW OF DHR CONFIRMED THE BATCH ID690 HAD BEEN PROCESSED IN 2003, MET ALL REQUIREMENTS AND TESTED TO SPECIFICATION (102 - 105 DEGREES F). THERE ARE NO OTHER REPORTS FOR THE LOT, INVENTORY ANALYSIS CONCLUDES WAS MANUFACTURED IN 07/2003. THE FACILITY, ACCORDING TO THE COMPLAINANT, CONVERTED TO ANOTHER PRODUCT, TRANSWARMER BRAND WAS "ATTRITIONED." ALL PRODUCT HAS BEEN REMOVED FROM THE FACILITY, WHILE THE ONE DEVICE IMPLICATED IN THIS EVENT HAS BEEN PLACED ON HOLD BY THE RISK MANAGEMENT DEPARTMENT. THE DFU WARNING INSTRUCTS, "MONITOR INFANT CORE TEMPERATURE AND CHECK INFANTS SKIN FOR REDNESS." (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2003, A PHONE CALL FROM A MANAGER IN PEDIATRIC CARE ALLEGED AN EIGHT MONTH OLD INFANT HAD BEEN PLACED ON A TRANSWARMER MATTRESS AND BURNS TO HIS BACK RESULTED. SEVERAL FOLLOW-UP CALLS WERE MADE BEGINNING (B)(6) TO ATTAIN ADDITIONAL DETAIL. DUE TO THE TIMING AND AVAILABILITY OF DESIGNATED STAFF, IT WAS EVENTUALLY DISCLOSED THAT THE PT HAD "A COUPLE OF SMALL BLISTERS ON HIS BACKSIDE, IT LOOKED AS IF HE HAD A REALLY BAD SUNBURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118981 TRANSWARMER INFANT TRANSPORT MATTRESS IMD COOPERSURGICAL, INC. ID690

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO