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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The criticool involved in the incident has not been returned to belmont for investigation.No clinilogger data has been provided for review.There is insufficient information available to determine a potential root cause at this time.Without results of the investigation, we note the following: 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." belmont has requested that both the unit and clinilogger data be returned for evaluation.No patient injury was reported.The manufacturing records for this serial number were reviewed and no anomalies were identified.A review of past complaints indicates that this was an isolated incident; no trend has been identified for this type of issue.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
The following report was received involving a criticool: "surface cord "seems too heavy" at connection to criticool machine, causes alarms and requires manual override · during first use, machine reverted to adult mode, requiring manual override.".

• Brand Name: CRITICOOL
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 12530694
• Report Number: 1219702-2021-00123
• Device Sequence Number: 4031742
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1