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

Catalog Number 100-00003

Device Problem Insufficient Heating (1287)

Patient Problem No Information (3190)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

The criticool was evaluated and we were unable to duplicate the customer complaint that the unit exhibited a "check core and operate" alarm; the system was found to be fully functional.The device will alarm if the sensors are not positioned appropriately, as it is unable to accurately read the temperature of the patient.The operator's manual provides the following statement: "the criticool device does not initiate thermoregulation if the core sensor is not properly inserted into the patient.Ensure that direct patient feedback is monitored at all times." we are currently working with the user facility to provide additional training to the staff.We will continue to monitor and trend similar reports of this nature.

Event Description

The user facility reported that in the middle of a case, there was an alarm to check core sensor and operate, and the unit stopped thermoregulation.Another device was used to complete the procedure.

• 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: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 8346080
• MDR Text Key: 136612219
• Report Number: 1219702-2019-00009
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100-00003
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1