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

Model Number RI-2

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Information (3190)

Event Date 01/18/2020

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 several transistors were damaged, which caused the circuit breaker to trip, and the unit to lose power.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 the unit.The manufacturing records for this serial number were reviewed and nothing notable was observed.Should additional information become available, a supplemental report will be submitted.

Event Description

"during a case on (b)(6) 2020, the unit lost power and kept tripping the circuit breaker during the reboot.Another rapid infuser was brought in to finish the case with no further issue.".

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston rd; billerica, ma
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston rd; billerica, ma
• Manufacturer Contact: joelle haun ; 780 boston rd; billerica, ma
• MDR Report Key: 9729620
• MDR Text Key: 191419277
• Report Number: 1219702-2020-00017
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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: 02/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1