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

Catalog Number	500-03536
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2023 belmont received an incident report from the user.The user indicated that this has occurred on 4 separate occasions.In the event the leak leads to a loss of thermoregulation of the patient, an alarm will generate to alert the user.The wrap can be exchanged to continue thermoregulation.We have confirmed that the wraps concerned have been disposed off and will not be available for investigation.Review of the retain sample for the lot was conducted and no issues were found.No other complaints for this lot have been noted from any other location.The user has been asked to provide information on the location of where the leaks occurred and if they have any photographs or video of the alleged leaks.Further follow up with the user will occur to try and determine specific use scenario.
Event or Problem Description
It was noticed during the care of a patient on pediatric icu that the cooling wrap was leaking.The wrap had been in use for 32 hours.The customer reported 4 separate occasions where these wraps have been identified as leaking.No additional information has been provided by the site.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01003
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01003
• Manufacturer Contact: daniel menzin ; 780 boston road; billerica, MA 01003
• MDR Report Key: 17410079
• Report Number: 1219792-2023-00036
• Device Sequence Number: 17632923
• Product Code: DWJ
• UDI-Device Identifier: 07290012127342
• UDI-Public: 7290012127342
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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 Catalogue Number: 500-03536
• Device Lot Number: M202661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown