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

Catalog Number 100-00004

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919)

Patient Problem Burn(s) (1757)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that criticool system used on a patient with a gentherm maxitherm lite wrap, instead of the required belmont curewrap.Patient suffered skin burns.

Manufacturer Narrative

The internal complaint file # (b)(4) has been assigned to this incident for traceability.The wrap involved in this incident was not returned to belmont.It was determined that the criticool system was used on a patient with a gentherm maxitherm lite wrap despite the user manual containing the following "the belmont medical technologies wrap is proprietary to belmont medical technologies and this is the only wrap authorized to be used with the criticool® system.Use of any other wrap with the system may harm the patient." there was no report that the reported burn required medical intervention to prevent a life-threatening condition or permanent impairment to the body.It was determined this incident was due to user error as a non-belmont wrap was utilized.This is the second report of this kind from the same location.No other reports of this kind have been noted from any other location/user.The customer was made aware of statement in the manual "warning!!! the belmont medical technologies wrap is proprietary to belmont medical technologies and this is the only wrap authorized to be used with the criticool® system.Use of any other wrap with the system may harm the patient." after review, root cause of the reported issue was isolated to user error from off label use of the device.It was determined that a gentherm maxitherm lite wrap was utilized with the criticool.The user criticool user manual states the following:"warning!!! the belmont medical technologies wrap is proprietary to belmont medical technologies and this is the only wrap authorized to be used with the criticool® system.Use of any other wrap with the system may harm the patient." the criticool unit involved in the incident was tested and no issues were identified.In order to ensure that such incident is not repeated moving forwrad, the user facility confirmed that all remaining gentherm maxitherm lite wraps were discarded.We will continue to monitor this type of incident and take further corrective and preventive actions if required.

• Brand Name: CRITICOOL
• Type of Device: 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: 18843168
• MDR Text Key: 337676029
• Report Number: 1219702-2024-00009
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290012127038
• UDI-Public: 7290012127038
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 100-00004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1