MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CUREWRAP¿ INFANT, 2.5-4KG; THERMAL REGULATING SYSTEM

Model Number	500-03518R
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal complaint file # (b)(4) has been logged for this incident for traceability.It was reported that a baby undergoing therapeutic hypothermia experienced leakage from the cooling mattress/wrap system during treatment.It was noted that leakage had occurred multiple times during the cooling period.In total, three cooling wraps were used prior to the final incident during the rewarming phase.The infant was found wet on four occasions during treatment.During the rewarming phase, with approximately 45 minutes remaining, leakage was again identified, which slowed the rewarming process.The medical team made the decision to remove the cooling mattress, dry the infant, and allow rewarming to continue without the device for the remaining duration.A user facility report was filed; therefore, belmont will file a report as per belmont procedure.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."all curewraps are 100% leak tested by the manufacturer prior to release for shipment.Multiple wraps from the reported incident were received and reviewed by belmont engineering.After flowing water through the wraps with a criticool unit, it was observed that leaks were seen from multiple locations around the top part of the wraps where the patient's head would be located during treatment.The leaks were observed from small puncture holes in the wrap.A belmont territory manager went onsite to investigate the leaking occurrences.It was identified that the leaks were occurring from patients undergoing brain monitoring with needle electrodes.The root cause of the leaks is consistent with user error from micro pricking of the wrap from the needle electrodes being utilized during brain monitoring.The customer was reminded to avoid inserting any sharp objects between the patient and the wrap.Local practice changes were implemented after consulting with the belmont territory manager onsite.No further leaks have been reported since implementing the practice changes.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.
Event or Problem Description
It was reported that a baby undergoing therapeutic hypothermia experienced leakage from the cooling mattress/wrap system during treatment.It was noted that leakage had occurred multiple times during the cooling period.In total, three cooling wraps were used prior to the final incident during the rewarming phase.The infant was found wet on four occasions during treatment.During the rewarming phase, with approximately 45 minutes remaining, leakage was again identified, which slowed the rewarming process.The medical team made the decision to remove the cooling mattress, dry the infant, and allow rewarming to continue without the device for the remaining duration.

• Brand Name: CUREWRAP¿ INFANT, 2.5-4KG
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: garet tierney ; 780 boston road; billerica, MA 01821
• MDR Report Key: 24524171
• Report Number: 1219702-2026-00012
• Device Sequence Number: 18564873
• Product Code: DWJ
• UDI-Device Identifier: 07290012127182
• UDI-Public: 7290012127182
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 500-03518R
• Device Lot Number: M251751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown