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

Model Number	RI-2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser has been received for evaluation, but the investigation is not yet complete.The manufacturing records for this serial number were reviewed and nothing notable was observed.We have reached out to the distributor to obtain additional information from the user facility.Upon completion of the investigation, a follow-up report will be submitted accordingly.
Event or Problem Description
It was reported that the rapid infuser exhibited a "valve fault" alarm (system error #208), and that there were double images on the display.Our distributor relayed the following report: "the customer informed us that the system has produced the error code 208 during normal use.The error showed up after 2 hours and can not be reset.It seems to be a permanent problem now.".

• 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: 9142823
• Report Number: 1219702-2019-00069
• Device Sequence Number: 16924840
• Product Code: LGZ
• UDI-Device Identifier: 40896128002754
• UDI-Public: (01)40896128002754
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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: RI-2
• Device Catalogue Number: 903-00037A-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1