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

Model Number	THERMOWRAP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The wrap was not returned to belmont for evaluation; however, upon reviewing the video provided by the user facility, we were able to confirm that leaking occurred from the bottom of the wrap.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 in this case.The library/retain sample for this lot number will be inspected and a supplemental report will be submitted.
Event or Problem Description
The user facility reported that a thermowrap leaked during use.
Additional Manufacturer Narrative
The wrap was not available to be returned to belmont for evaluation.Review of the video clip provided by the user facility indicated leaking from the bottom of the wrap, however without the ability to investigate the wrap a definitive root cause of the reported leak cannot be established.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 in this case.Samples of 2 thermowraps from production were tested on the allon system and no leaks were observed on either of the wraps.The manufacturing and leak testing history records for this thermowrap lot number were also reviewed and indicated that the lot was released without any deviations or anomalies.All thermowraps are 100% leak tested by the manufacturer prior to release for shipment.No patient injury was reported.A review of complaint records over the past two years indicate no previous reports of this type of failure.This is considered to be an isolated incident.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10116125
• Report Number: 1219702-2020-00042
• Device Sequence Number: 2319684
• Product Code: DWJ
• UDI-Device Identifier: 27290012127254
• UDI-Public: 27290012127254
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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 Expiration Date: 03/25/2024
• Device Model Number: THERMOWRAP
• Device Catalogue Number: 512-03160
• Device Lot Number: M190491
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1