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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 115V
Device Problem No Apparent Adverse Event (3189)
Patient Problem Erythema (1840)
Event Date 01/07/2021
Event Type  malfunction  
Manufacturer Narrative
Photographs provided by the user facility indicate red marks on the patient's back and knee, however it is unclear whether these are the result of burns, bruising, or another type of skin damage. At the time of the incident, the reporting department at the user facility was in possession of two belmont-owned demo/loaner criticool devices but was unable to determine which of the two serial numbers was involved. The criticools were returned to belmont at the end of the hospital's trial evaluation and were tested according to our standard operating procedures. Both units performed according to our specifications upon receipt. The nurse educator reported that the patient is in liver failure and on vasopressors; it was noted that these patients tend to have fragile skin. The department has reportedly used the criticools on several other patients without issue. Further follow up revealed that the wound nurse was unable to determine whether the reported markings on the patient were the result of pressure or burn, furthermore the nurse educator confirmed that the patients in the department (transplant icu) do have compromised skin. The manufacturing records for both serial numbers were reviewed and no anomalies were identified. A review of past complaints indicates that this is an isolated incident, no trend has been identified for this type of issue. Should additional information become available, a supplemental report will be provided.
 
Event Description
Belmont's sales representative received a report from the user facility that after using the criticool on a hyperthermic patient, the patient exhibited a burn mark on the knee and markings to his/her back. It was reported that the machine was set to 38 degrees c.
 
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Brand NameCRITICOOL
Type of DeviceTHERMAL REGULATING 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
sabrina belladue
780 boston road
billerica, MA 01821
9783307637
MDR Report Key11290009
MDR Text Key232148482
Report Number1219702-2021-00017
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number115V
Device Catalogue Number100-00003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Yes
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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