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

Model Number	115V
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that the criticool exhibited a "halt 1" alarm and subsequently exhibited a "halt 4" alarm after the device was restarted.Following receipt of the user facility's report, belmont's technical support engineer investigated the criticool and discovered a fine black powder around the pump, suggesting that the pump diaphragm loosened from the motor and caused the unit to exhibit the reported alarms.A root cause of the loosened pump diaphragm could not be established.The pump was replaced and the unit subsequently passed all test specifications.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 1" alarm when the system detects a flow problem in operation mode and exhibits a "halt 4" alarm when a flow problem is detected during self-test.In the event of a halt 1 or halt 4 alarm, the system disables by turning off the pump and displays an alarm message with instructions for corrective measure.It was reported that another criticool was used to proceed with the case; no patient injury was reported.A review of past complaints indicates that no trend has been identified for this type of issue.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's clinical specialist received a report from the user facility and reported the following: (b)(6) rn, called the hotline at 330am regarding a criticool that was showing a halt alarm.After 60 hrs of using the device on the patient the device displayed a "halt 1 please restart" alarm.The user turned the device off and waited a few seconds before turning it back on.The device then began displaying a "halt 4" alarm.".

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11457952
• Report Number: 1219702-2021-00038
• Device Sequence Number: 11716840
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: 02/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1