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
Event or Problem Description
The following report was received involving a criticool: "rewarmed infant: pt was cooled on transport, reaching therapeutic temperatures on 8/20 @ 2150.Pt placed on criticool machine upon admission 8/21 @ 0000.At 2000, noted to be warm, axillary 36.7 celsius while core temp read 32.7 celsius.Core temp cord replaced then machine replaced and patient reach therapeutic temperature again 8/21 @ 2115.".
Additional Manufacturer Narrative
The criticool involved in the incident has not been returned to belmont for investigation.No clinilogger data has been provided for review.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 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 and a troubleshooting guide is provided in the user manual.The system will alarm if the patient's temperature is above 38.5 degrees c, or if the core sensor is not in place.Belmont has requested that both the unit and clinilogger data be returned for evaluation.It was reported that the unit was replaced with another criticool and the patient subsequently reached therapeutic temperature again.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 supplemental report will be submitted when additional information becomes available.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 12530311
• Report Number: 1219702-2021-00122
• Device Sequence Number: 4031741
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1