MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, N. AMERICA; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number	905-00022
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The ac adapter of the belmont buddy lite fluid warmer became wet with blood.While trying to clean the device, the user used cavicide and sprayed the ac adapter without unplugging it from the electrical outlet, causing a short circuit on the power supply that generated sparks and smoke in the operating room (or).The operating room procedure was already completed at the time of the incident, no patient or user were harmed by this situation.The ac adapter and belmont buddy lite were removed from service.Operating room leadership conducted a procedure review with operating room personnel to review proper cleaning procedures of equipment that are contaminated with biological fluids.

• Brand Name: BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, N. AMERICA
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston rd; billerica MA 01821
• MDR Report Key: 11612730
• Report Number: 11612730
• Device Sequence Number: 2999342
• Product Code: BSB
• UDI-Device Identifier: 10896128002449
• UDI-Public: (01)10896128002449
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/01/2021
• Report Date (Section F): 04/01/2021

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: 905-00022
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/01/2021