MAUDE Adverse Event Report: BELMONT INSTRUMENT LLC RAPID INFUSER RI-2; WARMER, THERMAL, INFUSION FLUID

Model Number 903-00037

Device Problems Circuit Failure (1089); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Tripped circuit breaker and shutdown power to the operating room.Facilities department notified to help reset circuit breakers during a critical portion of surgery.

• Brand Name: RAPID INFUSER RI-2
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT INSTRUMENT LLC; 780 boston rd; billerica MA 01821
• MDR Report Key: 16768440
• MDR Text Key: 313579734
• Report Number: 16768440
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 903-00037
• Device Catalogue Number: RGA#RMA5164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male