MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM THERMOGARD XP; THERMAL REGULATING SYSTEM

Model Number 8700-0650

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

The customer reported that the thermogard xp ivtm system (s/n (b)(4)) was slowly warming the patient while in controlled rate mode.It is unknown what type of catheter was used and whether the catheter was replaced before initiating the rewarming phase.The customer did not provide additional information on whether there were any kinks, bends, or occlusions in suk and/or the catheter.No secondary temperature probe was used.No further information was provided.No consequences or impact to the patient.

Manufacturer Narrative

Patient data files were reviewed by the zoll service personnel.The patient's body temperature had been well maintained at 36 °c in max mode for about 24 hours before the controlled rate was selected at the target temperature of 36.5 °c.The patient's body temperature was 35.98 °c when controlled-rate-rewarming was started.It is unknown why the customer chose a controlled rate so close to the warming target temperature of 36.5 °c.During the rewarming phase of the treatment, the customer set the console first to a controlled rate of 0.15 °c/hour, then to 0.2 °c/hour, then to max, then to 0.15 °c/hour, and then to max again.The therapy ended when the patient's body temperature was 36.47 °c.The thermogard xp ivtm system (s/n (b)(4)) involved in the reported complaint will not be returned to zoll for evaluation and was not evaluated at the customer site because the customer/biomed tested the system, and the console passed functional testing.Therefore, the thermogard console was placed back for clinical use, and service was not required to be performed by zoll.

• Brand Name: ZOLL IVTM THERMOGARD XP
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13115336
• MDR Text Key: 283166801
• Report Number: 3010617000-2021-01247
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0650
• Device Catalogue Number: 8700-0650
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1