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	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was returned 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.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.The manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that there was no harm to the patient.We have requested that our distributor reach out to the user facility to try to obtain any additional details about the case.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
The user facility reported to our distributor that, during a procedure, there was a spark and the unit stopped working.The doctor had the staff switch to an fms 2000 and the operation was completed.The patient was not injured.

• 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: 8713824
• Report Number: 1219702-2019-00039
• Device Sequence Number: 2662955
• Product Code: LGZ
• UDI-Device Identifier: 10896128002777
• UDI-Public: (01)10896128002777
• Combination Product (Y/N): N
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 903-00039A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1