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

Device Problem Activation Problem (4042)

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

Event Date 06/01/2020

Event Type  malfunction  

Event Description

Belmont rapid infuser would not work when preparing for patient.A second belmont in department was used without issues.Original belmont sent to and evaluated by biomed.Biomed was unable to re-produce stated issue.

• Brand Name: BELMOT RAPID INFUSER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston rd; billerica MA 01821
• MDR Report Key: 10459801
• MDR Text Key: 204552871
• Report Number: 10459801
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 08/12/2020
• Date Report to Manufacturer: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10220 DA