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

Catalog Number	508-03518
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported that, while assessing the baby, the cooling blanket was noted to be leaking and a puddle was formed.Infant immediately changed to new cooling blanket, dried, and stabilized.Leaking blanket was set aside for an investigation.There is no patient harm associated with this incident.
Additional Manufacturer Narrative
The internal complaint file #cmp-002604 has been logged for this incident for traceability.We received the curewrap involved in this incident back for investigation on may 1st, 2023.Belmont received a medwatch report #1000060000-2023-8001 on (b)(6) 2023.The user reported that, while assessing the baby, the cooling blanket was noted to be leaking and a puddle was formed.Infant immediately changed to new cooling blanket, dried, and stabilized.Leaking blanket was set aside for an investigation.There is no patient harm associated with this incident 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.Evaluation: upon receipt of the referenced curewrap, belmont service engineers tested it with a known working criticool unit, it was found the wrap leak could be confirmed from the upper left portion of the wrap.The fabric of the wrap was reviewed under a microscope, and it was confirmed that the leak was due to a puncture in the material of the wrap.A precise root cause of this puncture could not be determined, however all wraps are 100% leak tested prior to release.If a leak occurs, the patient may get wet, however thermoregulation will continue.In the event thermoregulation cannot continue due to the leak, the device will alarm to alert the user.The wrap can be replaced to continue thermoregulation.Belmont has provided a box of replacement wraps to the user facility to resolve this issue.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 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 16952302
• Report Number: 1219702-2023-00024
• Device Sequence Number: 6850580
• Product Code: DWJ
• UDI-Device Identifier: 17290012127189
• UDI-Public: 17290012127189
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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 Catalogue Number: 508-03518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (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