BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STX VEST

    MDR report key: 19377536 · Received May 22, 2024

    Report

    Report Number
    3010617000-2024-00406
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    April 26, 2024
    Report Date
    January 3, 2025
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NZE
    PMA / PMN Number
    K231182
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THERMOGARD XP SURFACE PAD INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE THE CUSTOMER HAS DISPOSED OF IT, AND 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 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. 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, IN THIS CASE, IT WAS UNKNOWN IF THE PATIENT'S SKIN WAS CHECKED AS FREQUENTLY AS NEEDED. DUE TO THE RELEVANT TIME AND THE EVENT LOCATION IN PREDISPOSED PATIENT, THE EVENT OF SKIN BLISTERS WAS CAUSAL RELATED TO THE THERMOGARD XP SURFACE PADS. PER THERMOGARD¿ VEST (SURFACE PAD) INSTRUCTIONS FOR USE, CHECK THE PATIENT'S TEMPERATURE AND SKIN CONDITION, ESPECIALLY AREAS IN CONTACT WITH THE THERMOGARD VEST, AT LEAST EVERY 20 MINUTES OR AS DIRECTED BY A PHYSICIAN. PATIENTS VARY IN DEGREE OF SENSITIVITY TO COLD, HEAT, AND PRESSURE. PATIENTS AT GREATEST RISK ARE THOSE UNCONSCIOUS OR INCAPACITATED, PERSONS ON PROLONGED THERAPY, DIABETICS, CHILDREN, AND PERSONS WITH SENSITIVE SKIN AREAS OR POOR CIRCULATION. FOCUS ATTENTION ON ALL BONY PROMINENCES. ZOLL TERRITORY MANAGER RE-EDUCATED THE CUSTOMER ON IFU, AS USING SURFACE PADS IS NEW TO THIS FACILITY.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B1 (ADVERSE EVENT), B2 (OUTCOMES ATTRIBUTED TO ADVERSE EVENT) AND H1 (TYPE OF REPORTABLE EVENT).

    Description of Event or Problem · 0

    DURING THE NORMOTHERMIC PHASE OF THE SURFACE TEMPERATURE MANAGEMENT THERAPY USING THE THERMOGARD XP SURFACE (LOT #UNKNOWN), THE CUSTOMER REPORTED THAT THE PATIENT HAD A BLISTER ON THE LATERAL CHEST. THE PATIENT'S THERAPY WAS COMPLETED. THE ICU MANAGER MENTIONED THAT SKIN CHECKS WERE DOCUMENTED EVERY TWO HOURS DURING THE DAY SHIFT, PER HOSPITAL PROTOCOL; HOWEVER, THE ICU MANAGER DID NOT KNOW THE FREQUENCY ON THE NIGHT SHIFT. THE ICU MANAGER DENIED ANY OTHER CAUSES (E.G., MONITOR ELECTRODES BETWEEN THE PAD AND THE PATIENT'S SKIN). THE ICU MANAGER STATED THAT A CHEST TUBE WAS PLACED AT THE SAME LATERALITY; HOWEVER, THE TUBE WAS REMOVED BEFORE PAD PLACEMENT, AND THE DRESSING WAS NOT NEAR WHERE THE BLISTER OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749500 STX VEST CIRCULATING-FLUID WHOLE-BODY HEATING/COOLING SYSTEM PAD, SINGLE-USE NZE ZOLL CIRCULATION L/XL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other