BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOGARD¿ VEST, L/XL

    MDR report key: 19969843 · Received August 13, 2024

    Report

    Report Number
    3010617000-2024-00610
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 12, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NZE
    UDI-DI
    00849111076135
    PMA / PMN Number
    K231182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. 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 LISTED THAT THE METHOD OF TEMPERATURE CONTROL PROVIDED BY ALL HYPER-HYPOTHERMIA UNITS PRESENTS THE DANGER OF HEATING OR COOLING BODY TISSUES, PARTICULARLY THE SKIN, TO A POINT WHERE THEY ARE INJURED, I.E., BURNS OR FROSTBITE, RESPECTIVELY; AND THE RISK OF HURTING BY HEATING OR COOLING IS NOT UNIQUE TO BLANKETROL III CONSOLE WITH THE STX SURFACE COOLING PAD. A PHYSICIAN'S ORDER IS REQUIRED FOR SETTING PAD TEMPERATURE AND USE OF EQUIPMENT. AT LEAST EVERY 20 MINUTES, OR AS DIRECTED BY PHYSICIAN, CHECK PATIENT'S TEMPERATURE AND SKIN INTEGRITY OF AREAS IN CONTACT WITH PAD, HOWEVER, BASED ON AVAILABLE INFORMATION, THE NURSE STATED THAT THE PATIENT'S SKIN WAS NOT CHECKED AS FREQUENTLY AS NEEDED OR BASED ON THE PROTOCOLS, WHICH LED TO SKIN INTEGRITY ISSUES. RE-TRAIN THE USER FOR IFU IS RECOMMENDED. DUE TO THE RELEVANT TIME AND THE EVENT LOCATION IN PREDISPOSED PATIENT, THE EVENT OF SKIN DAMAGE WAS PROBABLY RELATED TO THE BLANKETROL III CONSOLE WITH THE STX SURFACE COOLING PAD. THE EVENT WAS CAUSALLY RELATED TO THE DEVICE AND PROCEDURE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT EXPERIENCED A SKIN INJURY WHILE UNDERGOING TREATMENT USING THE BLANKETROL III CONSOLE WITH THE STX SURFACE COOLING PAD (LOT# UNKNOWN) FOR TEMPERATURE MAINTENANCE. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491892 THERMOGARD¿ VEST, L/XL EXTERNAL CIRCULATING-FLUID CORE TEMPERATURE REGULATION SYSTEM PAD, SINGLE-USE NZE ZOLL CIRCULATION, INC. L/XL UNKNOWN 00849111076135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other