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

Model Number	RI-2
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser was returned to belmont for investigation and was tested using our standard operating procedures.Upon receipt, it was noted that several transistors on the driver boards were shorted, which caused the circuit breaker to trip.Without additional information, it is difficult to determine why the transistors were damaged.Further testing is being conducted.The operator's manual instructs the user, "ensure that the circuit breaker is easily accessible to turn off in an emergency situation" upon powering up the unit.It was reported that the implicated unit was immediately swapped out with another rapid infuser; there was no patient injury reported.We have remained in communication with our distributor to obtain additional information.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Our distributor received a complaint from the user facility and relayed the following report: "during a case, the ri-2 suddenly stopped running on ac and was in battery operation.We checked and found out the power outlet was tripped, this happened only after 4 hours through the case.Immediately we swapped to another fms for backup.".

• 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: 9365870
• Report Number: 1219702-2019-00089
• Device Sequence Number: 2973536
• Product Code: LGZ
• UDI-Device Identifier: 10896128002753
• UDI-Public: (01)10896128002753
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1