MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. THERMOGARD¿ VEST, L/XL; EXTERNAL CIRCULATING-FLUID CORE TEMPERATURE REGULATION SYSTEM PAD, SINGLE-USE

Model Number	L/XL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
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 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.
Event or Problem Description
Patient #2: 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 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.

• Brand Name: THERMOGARD¿ VEST, L/XL
• Common Device Name: EXTERNAL CIRCULATING-FLUID CORE TEMPERATURE REGULATION SYSTEM PAD, SINGLE-USE
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 24694825
• Report Number: 3010617000-2026-00170
• Device Sequence Number: 10463590
• Product Code: NZE
• UDI-Device Identifier: 00849111076135
• UDI-Public: 00849111076135
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: L/XL
• Device Catalogue Number: 8700-000938-01
• Device Lot Number: 222036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown