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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL

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BELMONT MEDICAL TECHNOLOGIES CRITICOOL Back to Search Results
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.
 
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Brand NameCRITICOOL
Manufacturer (Section D)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica MA
MDR Report Key14713025
MDR Text Key294157133
Report Number14713025
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07290107581110
UDI-Public07290107581110
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received06/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number115V
Device Catalogue Number200-00236
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/19/2022
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/16/2022 Patient Sequence Number: 1
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