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	Erythema (1840)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photographs provided by the user facility indicate red marks on the patient's back and knee, however it is unclear whether these are the result of burns, bruising, or another type of skin damage.At the time of the incident, the reporting department at the user facility was in possession of two belmont-owned demo/loaner criticool devices but was unable to determine which of the two serial numbers was involved.The criticools were returned to belmont at the end of the hospital's trial evaluation and were tested according to our standard operating procedures.Both units performed according to our specifications upon receipt.The nurse educator reported that the patient is in liver failure and on vasopressors; it was noted that these patients tend to have fragile skin.The department has reportedly used the criticools on several other patients without issue.Further follow up revealed that the wound nurse was unable to determine whether the reported markings on the patient were the result of pressure or burn, furthermore the nurse educator confirmed that the patients in the department (transplant icu) do have compromised skin.The manufacturing records for both serial numbers 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
Belmont's sales representative received a report from the user facility that after using the criticool on a hyperthermic patient, the patient exhibited a burn mark on the knee and markings to his/her back.It was reported that the machine was set to 38 degrees c.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11290009
• Report Number: 1219702-2021-00017
• Device Sequence Number: 3440916
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 01/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1