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

Model Number RI-2

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2020

Event Type  malfunction  

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 four transistors on the driver boards were shorted and damaged, which caused the circuit breaker to trip, and prevented the unit from powering up in ac mode.We were unable to determine the root cause of the damaged transistors.The user facility reported that when the unit was unplugged, it would continue to run.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adaptor for ungrounded outlets." the manual also instructs the user: "ensure that circuit breaker is easily accessible to turn off in an emergency situation." the manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that there was no injury to the patient.Should additional information become available, a supplemental report will be submitted.

Event Description

The user facility reported the following: "received call from (b)(6), anesthesia, that rapid infuser was turning off when using for 7 hours.The power switch would trip.When unit was unplugged, it continued to run.He tried multiple outlets, and in a different room , still would cause unit to turn off.".

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 10590644
• MDR Text Key: 208797345
• Report Number: 1219702-2020-00076
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1