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

Model Number	115V
Medical Device Problem Codes	Insufficient Cooling (1130); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The criticool has been returned to belmont for investigation; evaluation of the unit is in process.The user facility reported that while the criticool was in use, the patient was noted to be warmer than the set temperature and the device was not alarming.The alarm for a patient's high temperature can be configured in "settings"; the user can select from the following available values: 36°c, 36.5°c, 37°c, 37.5°c, 38°c, 38.5°c, and the alarm and message are issued according to the selected alarm limit.The operator's manual also provides recommended corrective actions in the event that the patient's temperature is above the set point.Without results of the investigation a root cause of the reported problem cannot be established.The user facility also reported that the criticool subsequently began exhibiting a "halt 4" alarm after it had been removed from use.The criticool is equipped with self-testing routines that continuously monitor system operation and displays a fault message in the event of a system fault.The unit exhibits a "halt 4" alarm when a flow problem is detected during self-test.In the event of a halt 4 alarm, the system disables by turning off the pump and displays an alarm message with instructions for corrective measure.The manufacturing and service records for this serial number were reviewed and no anomalies were identified.There was no patient injury reported.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Belmont medical technologies received the following report involving a criticool from the rn nurse specialist at the hospital: "the patient was noted to be warmer then the set temperature - the criticool was not alarming.The criticool unit was changed out to a blanketrol unit at that time.Our second criticool unit was in use at the time.Our staff tried to empty the unit after the change of equipment and the unit is now alarming - "halt 4" on the home screen.So we are unable to drain the existing water from the unit.".

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11742107
• Report Number: 1219702-2021-00061
• Device Sequence Number: 4219981
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 115V
• Device Catalogue Number: 100-00003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1