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

Model Number	CUREWRAP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The wrap has not been returned to belmont for evaluation.We have reached out to the distributor to obtain additional information about the case, and to determine whether the wrap is available to be returned for investigation.The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap.This may cause tearing and water leakage from the wrap." the following precaution is also provided: "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." without additional information, it is difficult to determine what occurred during the case at this time.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The user facility reported that a curewrap was leaking during a case.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10014281
• Report Number: 1219702-2020-00034
• Device Sequence Number: 14282565
• Product Code: DWJ
• UDI-Device Identifier: 07290012127175
• UDI-Public: 07290012127175
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

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: CUREWRAP
• Device Catalogue Number: 508-03500
• Device Lot Number: M182051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1