MAUDE Adverse Event Report: BK MEDICAL APS (PART OF GE HEALTHCARE) ULTRASOUND SCANNER SYSTEM 2300; BK3000 ULTRASOUND SYSTEM W/BATTERY

Model Number	2300-11
Medical Device Problem Codes	Smoking (1585); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, a customer reported a thermal event on their bk3000 system (s/n: (b)(6) ).While recharging in another room about an hour after the procedure, it was noticed that smoke was coming from the room and a fire in the power supply at the base of the machine was observed.Upon observation, the fire was extinguished.No harm to patients or users has been reported.
Additional Manufacturer Narrative
The product root cause was concluded to be: the internal power connection at the power inlet of the device came loose.This led to a gap between the power connector and y-splitter (the y-splitter is a power splitter component that splits mains power from 1 input to 2 outputs), which further led to the thermal event.

• Brand Name: ULTRASOUND SCANNER SYSTEM 2300
• Common Device Name: BK3000 ULTRASOUND SYSTEM W/BATTERY
• Manufacturer (Section D): BK MEDICAL APS (PART OF GE HEALTHCARE); mileparken 34; herlev, 2730 ; DA 2730
• Manufacturer (Section G): BK MEDICAL APS (PART OF GE HEALTHCARE); mileparken 34; herlev, 2730 ; DA 2730
• Manufacturer Contact: christoffer thaysen ; mileparken 34; herlev, 2730 ; DA 2730
• MDR Report Key: 20050894
• Report Number: 3003705156-2024-00001
• Device Sequence Number: 18142199
• Product Code: IYN
• UDI-Device Identifier: 05704916000264
• UDI-Public: 05704916000264
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K222441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 2300-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9680269-09/12/24-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown