MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number	FMS 2000
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomed at the hospital was unable to duplicate the complaint that the touch screen was frozen.The rapid infuser was subsequently returned for investigation and we were also unable to confirm the customer complaint regarding the touch screen; the unit performed according to our specifications upon receipt.The manufacturing records for this serial number were reviewed and nothing notable was observed.There was no patient injury reported.Without additional information, it is difficult to determine what occurred in this case.Upon reviewing complaints for the past year, it appears that this was an isolated incident; however, we will continue to monitor and trend similar reports of this nature.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The hospital biomed reported the following: "during a case on (b)(6) 2019 there was a report of the touch screen being frozen.Section of the touch screen did not function.The user repowered the unit but not able to resolve the issue.The hospital biomed was unable to confrim the issue in the lab.".

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 9236667
• Report Number: 1219702-2019-00078
• Device Sequence Number: 177912
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K032674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1