BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSWARMER INFANT TRANSPORT MATTRESS

    MDR report key: 23496115 · Received November 7, 2025

    Report

    Report Number
    23496115
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 17, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: FAILURE OF TRANS WARMER (INFANT TRANSPORT MATTRESS WITH WARMGEL) TO ADEQUATELY WARM UP WHEN ACTIVATED. WARMER IN L&D [LABOR AND DELIVERY] PREPARED FOR ACCEPTANCE OF 23+6 WEEKER BEING BORN EMERGENTLY WITH TRANS WARMER. UPON ADMISSION TO THE NICU [NEONATAL INTENSIVE CARE UNIT], BABY'S INITIAL TEMPERATURE WAS 36 DEGREES C. IT WAS DETERMINED THAT THE TRANS WARMER HAD NOT WARMED WHEN ACTIVATED. DURING THE ADMISSION PROCESS, NO LESS THAN 4 TRANS WARMERS WERE CRACKED AND ACTIVATED BUT DID NOT WARM. WE NEED TO ENSURE THAT THESE TRANS WARMER ARE CORRECTLY ACTIVATED AND WARM AS TO PREVENT A BABY FROM GETTING COLD. THERE SHOULD BE COMMUNICATION WITH THE COMPANY AS TO DETERMINE A POSSIBLE REASON FOR THE TRANS WARMER'S FAILURE TO ACTIVATE. PRODUCT USED: TRANS WARMER INFANT TRANSPORT MATTRESS WITH WARMGEL. REF: 20421. COMPANY: COOPER SURGICAL 95 CORPORATE DRIVE TRUMBULL, CT 06611.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781248 TRANSWARMER INFANT TRANSPORT MATTRESS PACK, HOT OR COLD, DISPOSABLE IMD COOPERSURGICAL, INC. 20421

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female