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	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser has been received for evaluation, but the investigation is not yet complete.The manufacturing records for this serial number were reviewed and nothing notable was observed.We have also reached out to the distributor to obtain additional information from the user facility, as there are ac input voltage requirements for operating the rapid infuser, which are specified in the operator's manual.Upon completion of the investigation, a follow-up report will be submitted accordingly.
Event or Problem Description
Our distributor received a complaint from the user facility and provided the following report: "while using our belmont, users discovered that the equipment was running on battery power and that the outlet on the power outlet was without voltage.(the indicator light on the plug was off).They moved the appliance cord to another outlet.The security of this withdrawal went immediately.The belmont unit got tried on a third course where the course fuse also went before the equipment was taken out of service.Other equipment that was in use also lost tension, so it became a situation that was experienced and in part became critical.We lost monitoring on the mx 700 but used the x2 on battery, as well as all infusion pumps went on battery.Due to the presence of technical personnel, they were quickly connected to the three course fuses so that the operation could continue without harm to the patient.".

• 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: 9048718
• Report Number: 1219702-2019-00061
• Device Sequence Number: 2181549
• Product Code: LGZ
• UDI-Device Identifier: 00896128002909
• UDI-Public: (01)00896128002909
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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: 09/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1