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

Model Number	INFANT CUREWRAP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The wrap has not been returned to belmont for evaluation.We have reached out to the user facility 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 an infant curewrap was leaking.
Additional Manufacturer Narrative
The incident occurred three months prior to being reported, therefore the wrap in question was not available for investigation and the reported leak could not be confirmed.A sample of two infant curewraps were removed from production and tested on a criticool system for approximately two hours; no leaks were observed.A review of the manufacturing and leak test records for this lot number indicated no deviations or anomalies.All curewraps are 100% leak tested by the manufacturer prior to being released for shipment.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." no report of patient harm.Belmont will continue to monitor and trend similar reports of this nature.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, ma ; 3307637
• MDR Report Key: 10048414
• Report Number: 1219702-2020-00038
• Device Sequence Number: 11492201
• Product Code: DWJ
• UDI-Device Identifier: 07290012127199
• UDI-Public: 07290012127199
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: INFANT CUREWRAP
• Device Catalogue Number: 500-03521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown