MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL; THERMAL REGULATING SYSTEM

Model Number	115V
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The criticool involved in the incident was returned to belmont for investigation on (b)(6)2021; evaluation of the unit is in process.No clinilogger data was available for review, therefore we are unable to confirm the report that the criticool was warming instead of cooling.There is insufficient information available to determine a potential root cause at this time.Without results of the investigation, we note the following: the criticool system offers a controlled rewarming function, which provides controlled gradual rewarming by increasing the set temperature by a fixed, small step related to the core temperature.The criticool device is equipped with self-testing routines that continuously monitor system operation.If a system fault or malfunction is detected, a fault message appears on the display.A troubleshooting guide is provided in the user manual should a malfunction occur.No patient injury was reported.The manufacturing records for this serial number were reviewed and no anomalies were identified.A review of past complaints indicates that this was an isolated incident; no trend has been identified for this type of issue.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported that the criticool was warming instead of cooling.
Additional Manufacturer Narrative
The criticool involved in the incident was returned to belmont for investigation.Upon receipt, it was determined that the tec board was not working properly on one side, which prevented the system from cooling as reported.The tec board was replaced, preventive maintenance services were performed, and the unit subsequently passed all testing.A root cause of the damaged board could not be determined.The criticool system offers a controlled rewarming function, which provides controlled gradual rewarming by increasing the set temperature by a fixed, small step related to the core temperature.The criticool device is equipped with self-testing routines that continuously monitor system operation.If a system fault or malfunction is detected, a fault message appears on the display.A troubleshooting guide is provided in the user manual should a malfunction occur.No patient injury was reported.The manufacturing records for this serial number were reviewed and no anomalies were identified.A review of past complaints indicates that this was an isolated incident; no trend has been identified for this type of issue.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING 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: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 12178522
• Report Number: 1219702-2021-00097
• Device Sequence Number: 16394092
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 115V
• Device Catalogue Number: 100-00003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown