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

Catalog Number	200-03548
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Device-Device Incompatibility (2919); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in uk reported that patient being actively cooled for neuroprotection.Patient placed on criticool cooling mattress, connected to machine and cooling commenced.Large amount of leaking from cooling mattress noted covering bed and patient.Cooling machine stopped, cooling mattress removed and patient changed.New cooling mattress put under patient and cooling restarted.No harm to patient.Hole noted at top of cooling mattress.Criticool lot number m223561 3548 picu techs and picu stores nursing lead aware and monitoring machine and cooling use for any further issues.Manufacturer already involved as previous issues with cooling mattress leaks.Manufacturer updated about recent incident.On investigation -arterial transducer clip was found to have been attached to the cooling mattress and the hole found was next to where the transducer had been attached to cooling mattress.This could have been the cause of the hole in the mattress.
Additional Manufacturer Narrative
The internal complaint file (b)(4) has been logged for this incident for traceability.The wrap involved in this incident was discarded after the procedure and therefore investigation is not possible.It was reported that the cooling machine stopped and new cooling mattress was put under patient after which cooling restarted.No harm to patient.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: we were not able to investigate since the mattress was discarded by the user.However the user indicated that upon their investigation - an arterial transducer clip was found to have been attached to the cooling mattress and the hole found was next to where the transducer had been attached to cooling mat.This could have been the cause of the hole in the mattress.There was no patient harm.A retain sample of the same lot was checked and no issues were noted.A review of complaints was conducted and no other complaints have been received for this lot.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: 19624004
• Report Number: 1219702-2024-00029
• Device Sequence Number: 12352227
• Product Code: DWJ
• UDI-Device Identifier: 17290012127387
• UDI-Public: 17290012127387
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: 200-03548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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