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

Model Number	115V
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that the criticool rewarmed the patient too quickly, rewarming at 0.5 degrees per hour instead of 0.25 degrees per hour.Following receipt of the complaint, belmont technical support contacted the initial reporter to review the system settings.The photo provided by the user revealed that the device was set to a rewarming rate of 0.5 degrees per hour, indicating that the patient had rewarmed at the set rate; the user had not verified the rewarm rate prior to use.In controlled rewarming mode, the criticool provides controlled gradual rewarming.The user can choose the final target temperature and the rewarming step rate.Instructions for setting the rewarming step are provided in the user manual.The criticool also offers two patient modes, adult and neonatal.The user manual states: "the default settings are different for adults and for neonates.Both can be set by the user per the protocol used at each hospital.The user should set the appropriate patient mode in settings when setting up the machine." the manual also instructs the user to do the following upon starting up the criticool system: "confirm that the patient mode is set to your desired choice (adult / neonate).If you wish to change the selection, refer to patient mode on 4-9." the criticool will not be returned to belmont for investigation, as it was determined that the device was operating as intended.The manufacturing and service records for this serial number were reviewed and no anomalies were identified.No patient injury was reported.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported that the criticool rewarmed the patient too quickly.

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 11925461
• Report Number: 1219702-2021-00075
• Device Sequence Number: 3202444
• 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): 06/02/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 115V
• Device Catalogue Number: 100-00003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1