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

Model Number	115V
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following receipt of the user facility's report, belmont's sales representative went to the hospital to investigate the unit and was unable to confirm the report that the criticool would not display a core temperature.Follow up revealed that the users did not try using a different temperature probe at the time of the incident.As a bad temperature probe can prevent the criticool from displaying a core temperature, the sales rep provided the user facility with a new core temperature cable.Belmont's techical support engineer subsequently went to the hospital and tested the entire unit and the system passed a full preventive maintenance.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 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 or Problem Description
The user facility reported that the criticool was not displaying a core temperature during transport of a patient.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11318193
• Report Number: 1219702-2021-00021
• Device Sequence Number: 17005234
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: 01/12/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1