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

Model Number	RI-2
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Belmont medical technologies has requested that the rapid infuser be returned for investigation, but the unit has not yet been received.Technical service inspected the cable and no issues were found.We have reached out to the distributor to obtain additional information from the user facility, as there are ac input voltage requirements for operating the rapid infuser, which are specified in the operator's manual.The manufacturing records for this serial number were reviewed, and nothing notable was observed.There was no patient injury reported.Without further information, it is difficult to determine what occurred in this incident.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
Belmont's distributor received a complaint from the user facility and relayed the following report, "device was attached to three different sockets and the fuse was always blown.Cable was checked by the technical service, but showed no deficits.".

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10484811
• Report Number: 1219702-2020-00067
• Device Sequence Number: 1240852
• Product Code: LGZ
• UDI-Device Identifier: 40896128002754
• UDI-Public: (01)40896128002754
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/02/2020

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1