THERMOGARD¿ VEST, L/XL

Additional Manufacturer Narrative

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 OF SKIN BLISTER WAS CAUSAL RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

Description of Event or Problem

PATIENT #1: DURING THE USE OF STX SURFACE PADS WITH BLANKETROL 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 BLISTERING TO THE POINT OF BLEEDING, WITH INDENTATIONS MIRRORING A HONEYCOMB SHAPE. 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.