BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOGARD¿ VEST, L/XL

    MDR report key: 24695388 · Received March 25, 2026

    Report

    Report Number
    3010617000-2026-00167
    Event Type
    Injury
    Date Received
    March 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NZE
    UDI-DI
    00849111076135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED. THE STX SURFACE PAD (LOT # 222036) INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED TO ZOLL FOR INVESTIGATION, AS NO MALFUNCTION OCCURRED. BASED ON AVAILABLE INFORMATION, THE EVENT WAS NOT SERIOUS BECAUSE IT DID NOT MEET ANY CRITERIA OF SERIOUSNESS PER REGULATIONS (DID NOT LEAD TO DEATH, WAS NOT LIFE-THREATENING, DID NOT RESULT IN A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION, DID NOT REQUIRE IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION, AND DID NOT RESULT IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION). IN IFU, IT STATES THAT A PHYSICIAN'S ORDER IS REQUIRED TO SET THE PAD TEMPERATURE AND USE THE EQUIPMENT. AT LEAST EVERY 20 MINUTES, OR AS DIRECTED BY THE PHYSICIAN, CHECK THE PATIENT'S TEMPERATURE AND THE SKIN INTEGRITY OF THE AREAS IN CONTACT WITH THE PAD. IN THIS CASE, SKIN CHECKS WERE PERFORMED ONLY EVERY 2 HOURS. DUE TO THE RELEVANT TIME AND THE EVENT LOCATION, THE EVENT OF SKIN BLISTER WAS CAUSAL RELATED TO THE STX SURFACE PADS. THE EVENT NAME WAS CHANGED FROM SKIN BLISTER TO SKIN BREAKDOWN, WHICH IS THE HIGHER TERM OF SKIN DAMAGE. THE EVENT OF SKIN BREAKDOWN WAS CAUSAL RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    PATIENT # 3: DURING THE USE OF STX SURFACE PADS WITH BLANKET ROL FOR POST-CARDIAC ARREST THERAPY TO COOL A PATIENT TO 36°C, THE NURSE OBSERVED SKIN BREAKDOWN ON THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT DEVELOPED BRUISE-LIKE CHANGES ON THE BACK WITHOUT NOTABLE INVOLVEMENT OR SCARRING. ACCORDING TO THE CUSTOMER, THE PADS WERE NOT APPLIED TOO TIGHTLY, AND THE NURSING STAFF WAS DOING SKIN CHECKS EVERY 2 HOURS. THE CUSTOMER ALSO STATED THAT THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH APPROPRIATE CORE TEMPERATURE MONITORING AND PROPER EQUIPMENT FUNCTION THROUGHOUT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745324 THERMOGARD¿ VEST, L/XL EXTERNAL CIRCULATING-FLUID CORE TEMPERATURE REGULATION SYSTEM PAD, SINGLE-USE NZE ZOLL CIRCULATION L/XL 222036 00849111076135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other