MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL

Model Number 115V

Device Problem Unexpected Shutdown (4019)

Patient Problem Respiratory Distress Syndrome of Newborns (2046)

Event Date 04/19/2022

Event Type  Death  

Event 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
• MDR Text Key: 294157133
• Report Number: 14713025
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 4 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White