BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSWARMER INFANT TRANSPORT MATTRESS

    MDR report key: 20694223 · Received November 15, 2024

    Report

    Report Number
    1216677-2024-00063
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    September 1, 2024
    Report Date
    January 7, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    IMD
    UDI-DI
    00888937025767
    PMA / PMN Number
    K934631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B4, D4, G3, G6, H2, H3, H4, H6, H11. DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM PRISTECH PRODUCTS INC ON 3/5/24 AND SOLD ON BETWEEN (B)(6) 2024 - (B)(6) 2024. MANUFACTURING RECORD REVIEW. DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW. IQC RECORD 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. TWO CONFIRMED SIMILAR COMPLAINTS WERE 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. 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: MEDSUN: UF/IMPORTER REPORT #: (B)(4). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSWARMER MATTRESS WAS ACTIVATED BEFORE PUTTING THE BABY BACK IN ISOLETTE. THE ISOLETTE WAS KEPT WARM AT 25 DEGREES CELSIUS IN MANUAL MODE. STAFF REPORTS BEING UNABLE TO OBTAIN TEMPERATURE. INFANT WAS TRANSPORTED TO MRI FOR 3 HOURS, UPON RETURN TO NICU, IT WAS NOTED THAT THE MATTRESS WAS NOT WARM AND THE INFANT HAD A LOW BODY TEMPERATURE. NO PATIENT HARM REPORTED. 1216677-2024-00063 20421 TRANSWARMER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55361 TRANSWARMER INFANT TRANSPORT MATTRESS REACTIVE-GEL HEATING PAD IMD COOPERSURGICAL, INC. 20421 IL504 00888937025767

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male