BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSWARMER INFANT TRANSPORT MATTRESS

    MDR report key: 18802036 · Received February 28, 2024

    Report

    Report Number
    1216677-2024-00005
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    January 19, 2024
    Report Date
    April 16, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    IMD
    UDI-DI
    00888937025767
    PMA / PMN Number
    K934631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM PRISTECH PRODUCTS INC. ON 4/14/23 AND SOLD BETWEEN 4/25/23 - 8/7/23. MANUFACTURING RECORD REVIEW DHR IN IQC RECORD-(B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW IQC RECORD-(B)(4) ATTACHED WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. THERE WERE SEVERAL COMPLAINTS THAT COULD NOT BE CONFIRMED, ALONG WITH 2 COMPLAINT THAT WERE SENT TO THE SUPPLIER FOR EVALUATION AND FOUND TO HAVE TEARS IN THE MATTRESSES WHICH CAUSED THEM TO ACTIVATE AND THEREFORE, CONFIRMING THE COMPLAINTS. IN THOSE COMPLAINTS, THE DAMAGE TO THE PRODUCT WAS ATTRIBUTED TO SHIPPING DAMAGE. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. NOTE: DEVICE INSTRUCTIONS FOR USE (IFU) SPECIFY THAT THE INFANT'S CORE TEMPERATURE SHOULD BE TAKEN ROUTINELY AND REGULARLY. ATTEMPTS FOR FURTHER DETAILS WERE MADE, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. FURTHER CORRECTIVE ACTION WOULD REQUIRE THE COMPLAINT PRODUCT TO BE RETURNED TO THE SUPPLIER FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: UNITED KINGDOM. OTHER: MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) 2024/001/031/501/007 DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INFANT WAS ADMITTED TO THE STABILIZATION ROOM ON TRANSWARMER, IN INCUBATOR ON (B)(6), 2024. BABY HAD A LOW ADMISSION TEMPERATURE. UPON CHECKING THE TRANSWARMER IT WAS COLD, CONTRIBUTING THE LOW ADMISSION TEMPERATURE. A SECOND TRANSWARMER FROM THE SAME LOT WAS OPENED AND FOUND TO ALSO NOT ACTIVATE. DEVICE INSTRUCTIONS FOR USE (IFU) SPECIFY THAT THE INFANT'S CORE TEMPERATURE SHOULD BE TAKEN ROUTINELY AND REGULARLY. ATTEMPTS FOR FURTHER DETAILS WERE MADE, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. 1216677-2024-00005 20421 TRANSWARMER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733755 TRANSWARMER INFANT TRANSPORT MATTRESS REACTIVE-GEL HEATING PAD IMD COOPERSURGICAL, INC. 20421 IL324 00888937025767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention