BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSWARMER INFANT TRANSPORT MATTRESS

    MDR report key: 20918299 · Received December 12, 2024

    Report

    Report Number
    1216677-2024-00067
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 22, 2024
    Report Date
    January 28, 2025
    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
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED: B4, G3, G6, H2, H3, H6, H11. CORRECTION: A2. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM PRISTECH PRODUCTS INC. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. SHOULD THE COMPLAINT PRODUCT LOT/SERIAL NUMBER BE PROVIDED GOING FORWARD, THE DEVICE HISTORY RECORD WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED BECAUSE THE COMPLAINT PRODUCT LOT NUMBER WAS NOT PROVIDED. SHOULD THE COMPLAINT PRODUCT LOT NUMBER BE PROVIDED GOING FORWARD, THE INCOMING INSPECTION REPORT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. 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, HOWEVER BOTH COMPLAINTS COULD NOT BE CONFIRMED. 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. ANY RELEVENT CUSTOMER OR CLINICAL INFORMATION: THE CUSTOMER ADVISED THE INFANT WAS ON THE MATTRESS LONGER THAN THE 10-MINUTES RECOMMENDED IN THE IFU AND REGULAR SKIN/TEMPERATURE CHECKS WERE MOST LIKELY NOT PERFORMED PER THE INSTRUCTIONS FOUND ON THE IFU. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. REQUESTED FURTHER INFORMATION FROM THE CUSTOMER TO SUPPORT THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 22-WEEK INFANT WAS EXPERIENCING SKIN BREAKDOWNS AFTER USING THE TRANSWARMER MATTRESS. FROM THE REPORTS OF THE NURSES PRESENT, THERE WAS ONE BLANKET PLACED BETWEEN THE BABY AND THE MATTRESS AT THE TIME OF DELIVERY. THE INFANT WAS HAVING UMBILICAL LINES PLACED SO THE INFANT REMAINED ON THE MATTRESS FOR MUCH LONGER THAN THE RECOMMENDED 10-MINUTE GUIDELINE IN ORDER TO KEEP HIM WARM. AFTER LINE PLACEMENT, IT WAS FOUND THAT THE INFANT WAS COLD, SO THE TEAM LEFT THE BABY ON THE MATTRESS BUT REPLACED THE BLANKET WITH A FLEECE LINER. NO ADDITIONAL INFORMATION IS AVAILABLE. 20421 TRANSWARMER 2024-11-0000467.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936687 TRANSWARMER INFANT TRANSPORT MATTRESS REACTIVE-GEL HEATING PAD IMD COOPERSURGICAL, INC. 20421 UNKNOWN 00888937025767

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Other