MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION THE BELMONT HYPERTHERMIA PUMP; THERMAL INFUSION FLUID WARMER

Model Number	HYPERTHERMIA PUMP
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation and was tested using our standard operating procedures.We were unable to confirm the customer complaint that the unit lost power during a case.We evaluated the unit and identified an ic on driver a board as shorted, which caused the unit to exhibit a "heater power i/o fault" alarm.We are unable to determine the root cause of the shorted ic.It was reported that there was no harm to the patient.The unit was replaced during the procedure and the case was successfully completed.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that the unit lost power during a case.Another hyperthermia pump was brought in and the case was finished successfully.No injury to the patient.

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston road; billerica MA 01821
• MDR Report Key: 7534848
• Report Number: 1219702-2018-00008
• Device Sequence Number: 16188958
• Product Code: LGZ
• UDI-Device Identifier: 10896128002456
• UDI-Public: (01)10896128002456
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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?: No
• Operator of Device: No Information
• Device Model Number: HYPERTHERMIA PUMP
• Device Catalogue Number: 902-00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1