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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The infant curewrap involved in the incident was not available for investigation.No photos were provided.Without the ability to investigate the wrap, a root cause of the reported leak cannot be established.The operator's manual informs the user, "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." the manual also provides a troubleshooting guide for water leaks, as well as the following warning statement: "water may drip from the inlet tubes of the wraps.Be sure that no electrical device or outlet is located under the criticool's water inlet or wrap tubes.When disconnecting wraps from the criticool confirm that the clamps are tight, to prevent water leaking from the wrap." a review of past complaints indicates that there have been no other complaints related to this lot number.All curewraps are 100% leak tested by the manufacturer prior to release for shipment.No patient injury was reported.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont medical technologies received a report from the user facility that an infant curewrap leak started as a slow drip and became a consistent spray when clamped.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 12028775
• Report Number: 1219702-2021-00085
• Device Sequence Number: 4543440
• Product Code: DWJ
• UDI-Device Identifier: 07290012127182
• UDI-Public: 07290012127182
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 500-03518
• Device Lot Number: M200061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1