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

Model Number 115V

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2021

Event Type  malfunction  

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 Description

The user facility reported that the criticool rewarmed the patient too quickly.

• 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: 11925461
• MDR Text Key: 263423720
• Report Number: 1219702-2021-00075
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 115V
• Device Catalogue Number: 100-00003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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