BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCMATT

    MDR report key: 22456456 · Received July 9, 2025

    Report

    Report Number
    22456456
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 20, 2025
    Manufacturer
    TEC COM MEDIZINTECHNIK GMBH
    Product Code
    FOH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT WAS ON TECOTHERM FOR THERAPEUTIC HYPOTHERMIA, REWARMING PHASE STARTED AT 1902. AT 1945 AFTER CARES NOTED LARGE WET SPOT ON BLANKED ON BED AT THE BOTTOM, NEAR THE CONNECTION PORT OF THE MATTRESS. CHARGE RN CALLED TO BEDSIDE TO HELP ASSESS. FOUND VERY TINY HOLE IN THE MATTRESS AT THE CORNER EDGE NEXT TO WHERE THE HOSES CONNECT. DISCUSSED CHANGING OUT MATTRESS, BUT SINCE SHE ONLY HAD A FEW MORE HOURS OF REWARMING TRIALED TAPING OVER THE SITE AND PLACED A CHUCKS PAD UNDERNEATH. NO FURTHER LEAKING NOTED, INFANT-MAINTAINED CORE TEMPS PER REWARMING PHASE. SAVED MATTRESS FOR MANAGEMENT AFTER WARMING PHASE COMPLETED AND TECOTHERM DISCONTINUED. SITE CONFIRMED DEFECT, [REDACTED] REPLIED ASKING FOR PRODUCT IDS. [DATE REDACTED] SENT ON UPS TRK# [REDACTED]. MANUFACTURER RESPONSE FOR TECOTHERM DISPOSABLE AQUA WRAP, TECOTHERM DISPOSABLE AQUA WRAP (PER SITE REPORTER). [REDACTED] SENT ON UPS TRK# [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577268 TCMATT MATTRESS, WATER, TEMPERATURE REGULATED FOH TEC COM MEDIZINTECHNIK GMBH NEOSINGLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown