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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL THERMOREGULATION SYSTEM

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BELMONT MEDICAL TECHNOLOGIES CRITICOOL THERMOREGULATION SYSTEM Back to Search Results
Catalog Number 100-00003
Device Problem Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 04/20/2022
Event Type  Death  
Manufacturer Narrative
The internal complaint file # (b)(4) has been logged for this incident for traceability. Belmont has not yet received the unit back for investigation. When the service engineer reached out the user facility on may 18th, they confirmed that they are working on sending the device back for investigation. Belmont reached the user facility but,the users were unable to confirm if halt one came in first, then continuous halt 4's. If the device sounds an alarm and/or presents a display other than the standard belmont medical technologies display, the operator should proceed according to the display message and/or the troubleshooting instructions the device could have most likely displayed halt 1 message with instructions for corrective actions: "please restart". When criticool detects either of the following conditions, it may display halt 1 or halt 4: system detected a flow problem in operation mode; flow less than 0. 1 bar for more than 2 minutes; flow greater than 0. 9 bar for more than 2 minutes. The operator's manual also provides possible conditions and additional recommended operator actions. Since the halt 4 only occurs during the system start up, it would mean the system was not actually in use on the patient. The device would have to have been a halt 1 during the procedure, then the system would have had halt 4 during start up consistently. Without having the unit for investigation it is difficult to determine whether the unit malfunctioned or not. The manufacturing records for this serial number were reviewed and no anomalies were identified. 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
The biomed reported a halt 4 while using criticool. Belmont received confirmation from biomed on 20th april that this occurred in a case and the patient expired. Criticool generates halt 4 only during the system start up, which suggests that the system was not on the patient. The system should have generated halt 1 during the procedure, then it would have had halt 4 during start up consistently. Belmont followed up with the user facility several times to confirm if the system ever generated halt 1 but, received no updates to date.
 
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Brand NameCRITICOOL
Type of DeviceTHERMOREGULATION 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 Key14466665
MDR Text Key292342010
Report Number1219702-2022-00023
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07290012127021
UDI-Public7290012127021
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083662
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Remedial Action Inspection
Type of Report Initial
Report Date 05/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number100-00003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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