MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL

Model Number	115V
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Respiratory Distress Syndrome of Newborns (2046)
Date of Event	04/19/2022
Type of Reportable Event	Death
Event or Problem Description
Criticool machine displayed "halt restart" on screen and machine stopped cooling pt.Machine was restarted but didn't work at all.Cooling function never resumed.Pt unable to be rewarmed in a controllec environment.

• Brand Name: CRITICOOL
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA
• MDR Report Key: 14713025
• Report Number: 14713025
• Device Sequence Number: 5234036
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/04/2022
• Report Date (Section F): 05/04/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2022
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 4 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White