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

Model Number 115V

Device Problem No Apparent Adverse Event (3189)

Patient Problem Erythema (1840)

Event Date 01/07/2021

Event Type  malfunction  

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 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
• Type of Device: 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: 11290009
• MDR Text Key: 232148482
• Report Number: 1219702-2021-00017
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1