MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL; THERMOREGULATION SYSTEM

Catalog Number 100-00003

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

Belmont internal complaint file: (b)(4) has been logged for this incident for traceability.Belmont has not received the unit for investigation despite requesting the unit be returned.Belmont reached out to the on 3/21 for additional information from the user via e mail and has not received any further feedback to date.Without having the unit for investigation it is difficult to determine whether the unit malfunctioned or not.The criticool could have worked exactly as intended.Criticool avoids overshooting as it gets closer and closer to set point temp.Set point range is within 0.3 degrees in either direction of the set point.In controlled rewarming mode, the target temp is 36.5.Therefore, if the patient reached 36.2, criticool would consider the patient already at set point range.If the hospital is looking for the patient to reach exactly 36.5, they might want to set the set point temp to 36.8, which would mean a core temp of 36.5-37.1 would be acceptable.The manufacturing records for this serial number were reviewed and no anomalies were identified.A review of past complaints indicates that this is an isolated incident, no trend has been identified for this type of issue.Should additional information become available, a supplemental report will be provided.

Event Description

Patient was in the process of rewarming from theraputic hypothermia during the day.Patient's core temp remained at 36.1 - 36.2c for 6 hours and never reached target temp.Patient felt warm to touch and axillary temps were normal.Discussed with provider and hypothermia super-user about the situation.Decided to manually rewarm patient by removing blanket and titrating temps with radiant warmer gradually.There was no harm in this event.

• Brand Name: CRITICOOL
• Type of Device: THERMOREGULATION SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821 ; 9786630214
• MDR Report Key: 14240938
• MDR Text Key: 297255944
• Report Number: 1219702-2022-00012
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290012127021
• UDI-Public: 7290012127021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100-00003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• 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