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

Model Number	FMS 2000
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser involved in the incident has not been returned to belmont for investigation.The unit power may be affected by an issue with the ac power source or power cord connection, however without investigating the device a root cause cannot be established.The operator's manual provides ac input voltage requirements for operating the rapid infuser, as well as a troubleshooting guide including possible conditions and recommended operator actions in the event that the unit has no power.The manufacturing records and service records for this serial number were reviewed and no anomalies were identified; the unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2011.It was reported that the user was able to restart the unit and finish the case; no patient injury was reported.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported that the rapid infuser, fms 2000 shut down momentarily during a case.The user was able to repower the unit and complete the procedure.

• 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: 11325945
• Report Number: 1219702-2021-00023
• Device Sequence Number: 11624035
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1