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

Model Number 115V

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Following receipt of the user facility's report, belmont's sales representative went to the hospital to investigate the unit and was unable to confirm the report that the criticool would not display a core temperature.Follow up revealed that the users did not try using a different temperature probe at the time of the incident.As a bad temperature probe can prevent the criticool from displaying a core temperature, the sales rep provided the user facility with a new core temperature cable.Belmont's techical support engineer subsequently went to the hospital and tested the entire unit and the system passed a full preventive maintenance.No patient injury was reported.The manufacturing records for this serial number 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

The user facility reported that the criticool was not displaying a core temperature during transport of a patient.

• Brand Name: CRITICOOL
• Type of Device: THERMAL 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 Key: 11318193
• MDR Text Key: 231978648
• Report Number: 1219702-2021-00021
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290107581110
• UDI-Public: 07290107581110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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: 100-00003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• 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: Unknown
• Patient Sequence Number: 1