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

Catalog Number 100-00004

Device Problems Use of Incorrect Control/Treatment Settings (1126); Temperature Problem (3022)

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

Event Date 02/11/2024

Event Type  malfunction  

Manufacturer Narrative

The internal complaint file #(b)(4) has been logged for this incident for traceability.The device involved in this incident was not returned to belmont for investigation.This issue is obvious to the user as the patient's temperature values are continuously displayed on the screen.Other methods of thermoregulation can be used to warm the patient faster.Criticool setting was altered so that the re-warming would take place at the required times and not on the adult setting.Patient re-warmed with delay.The neonate was monitored throughout with skin and rectal temperature probes.Patient remains ventilated which is not a result of the delayed re-warming.The medical team and parents were informed.Within the criticool unit, patient mode is displayed in the top left section titled "patient".The selected patient mode is highlighted with a white box.In this scenario, adult mode is selected.To select a different mode, press the desired patient mode, either neonatal or adult.The new patient mode is highlighted with a white box.The user manual also contains the following note: "the neonatal and adult modes have different settings during operation".There was no report of patient injury as a result of the alleged incident.Belmont has contacted the user to request additional information and clinilogger data about the alleged incident.Without having the unit or clinilogger data for investigation, it is not possible to determine whether the unit malfunctioned or not.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.

Event Description

Belmont received mir reference number (b)(4) which detailed the following; a neonate was programmed for rewarming on the criticool after being actively cooled.The rewarming process was expected to be within 6 hours but noted to have taken excessively longer as the neonate attained temperature approximately 16hours afterwards.The device was reviewed and noted to be on the 'adult' setting rather than the 'infant' /neonatal setting, this accounted for the delay.The device was suspected to be preset to the 'adult' setting which is not expected for a device that was designated for neonates.

• 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: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 19001523
• MDR Text Key: 339334653
• Report Number: 1219702-2024-00015
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290012127038
• UDI-Public: 7290012127038
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100-00004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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