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

Model Number	115V
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported the following: "while the criticool is running, connected to the child for more than 20 hours, the criticool starts ringing when the patient is not being cared for (without the patient moving or anything else) and indicates the following message: "restart the device", which we do by turning the device off and on again, since no manoeuvre is possible from the device's control panel.Once the device is turned on again, the loading screen appears, but after two small loading squares it does not move forward, and the "restart the device" error screen appears again.We perform the maneuver three times without success.It is then impossible for us to have access to the temperature control panel of the patient, or even to know if the cooling is still in progress.Given the seriousness of the situation, a second device borrowed from the pediatric resuscitation unit is used to continue therapeutic hypothermia on the patient.".
Additional Manufacturer Narrative
The criticool unit involved in the incident has not been returned to belmont medical technologies for investigation.When the device prompts a restart of the system, as described by the user, it is always associated with a halt message/alarm.When the criticool detects a halt condition, it disables the device by turning off the pump, turning off the tecs, activating the bypass, and turning on the buzzer; additionally, the soft-touch keys are disabled.As the hospital did not provide the specific halt/alarm message or error number exhibited, belmont has followed up with the distributor to obtain additional information from the user.As of the date of this report, no other details are available.Furthermore, there is no clinilogger data available for review.As the device has not been evaluated by belmont, nor is there information about the alarm or clinilogger data available, it is not possible to determine a root cause at this time.There is no indication of patient harm as a result of the reported incident; another criticool device was used to continue therapy on the patient.The hospital reported that there were no visual clinical signs on the child.A review of past complaints indicates that this was an isolated incident.A final report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The criticool unit involved in the incident has not been returned to belmont medical technologies for investigation.When the device prompts a restart of the system, as described by the user, it is always associated with a halt message/alarm.When the criticool detects a halt condition, it disables the device by turning off the pump, turning off the tecs, activating the bypass, and turning on the buzzer; additionally, the soft-touch keys are disabled.Belmont medical technologies requested additional information to clarify what halt alarms were generated during the event, however this information was unknown.It was determined that no clinilogger was attached to the device, therefore no information regarding the event could be obtained from the clinilogger file.Multiple requests were made to obtain additional information regarding the event however no response was received.No device malfunction could be verified and the root cause of the reported issue could not be determined.It was reported that another criticool was used to finish the procedure; there was no harm to the patient.Belmont will continue to monitor similar reports of this nature and take further action if necessary.

• 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: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 13311846
• Report Number: 1219702-2022-00003
• Device Sequence Number: 4944863
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 200-00236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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