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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL THERMAL REGULATING SYSTEM

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BELMONT MEDICAL TECHNOLOGIES CRITICOOL THERMAL REGULATING SYSTEM Back to Search Results
Model Number INFANT CUREWRAP
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The wraps have not been returned to belmont for evaluation. We have reached out to the hospital to obtain additional information about the case, and to request that the wraps be returned for investigation. The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap. This may cause tearing and water leakage from the wrap. " the following precaution is also provided: "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding. " without additional information, it is difficult to determine what occurred during the case at this time. Should additional information become available, a supplemental report will be submitted.
 
Event Description
The user facility reported the following: "we have had to use our criticool machine a few times in the last month. Each time, nursing staff has reported that the cooling wrap was leaking and had to be replaced. Today, two wraps in a row were leaking and required replacement. It is only the area directly under the baby that seems to leak, it is not at a connection point with the hoses that is causing the problem. Lot # m190841 exp 3/25/2024. ".
 
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Brand NameCRITICOOL
Type of DeviceTHERMAL REGULATING SYSTEM
Manufacturer (Section D)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica, ma
Manufacturer (Section G)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica, ma
Manufacturer Contact
sabrina belladue
780 boston road
billerica, ma 
3307637
MDR Report Key9833116
MDR Text Key198688465
Report Number1219702-2020-00027
Device Sequence Number1
Product Code DWJ
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 Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberINFANT CUREWRAP
Device Catalogue Number508-03521
Device Lot NumberM190841
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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