STX VEST

Description of Event or Problem

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.

Additional Manufacturer Narrative

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

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