MAUDE Adverse Event Report: BK MEDICAL APS FLEX FOCUS 800 SYSTEM; ULTRASOUND PULSED DOPPLER IMAGING SYSTEM

Model Number	FLEX FOCUS 800 SYSTEM
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit was replaced with a loaner unit.The facility would not allow the service technician to remove the device from their premises.
Event or Problem Description
In the or during a robotic surgery case with the use of the bk medical ultrasound system at approximately 10:30 am, with the ultrasound plugged into the wall, a nurse noticed a noise and saw smoke coming from the back of flex focus 800 ultrasound s/n (b)(4) with ua1214 keyboard stand s/n (b)(4).The orderly immediately unplugged the unit from the wall and brought into the hallway.At this time, the unit was still smoking and the orderly used a water fire extinguisher on the ultrasound concentrating on the battery bay area on the ua1214.Next a fire alarm was pulled and the bio-med tech showed up with a replacement flex 800.The bio-med tech saw the batteries catch fire when the water was applied.The fire did go out after a short time.When the fire dept.Showed up the fire was out.They removed the equipment and brought it down to the bio-med shop.The bio-med engineer did not know the status of the charge before incident.They did say the nurses saw the warning to replace the batteries on the screen.The biomed department had just ordered 6 new batteries to replace on all 3 ultrasounds but did not have a chance to replace on this unit yet.They were not aware there were 4 batteries in this unit when he ordered them.Bio-med had no knowledge of damage to the batteries or the ultrasound before the incident.

• Brand Name: FLEX FOCUS 800 SYSTEM
• Common Device Name: ULTRASOUND PULSED DOPPLER IMAGING SYSTEM
• Manufacturer (Section D): BK MEDICAL APS; mileparken 34; 2730; herlev, ; DA
• MDR Report Key: 7133582
• Report Number: 9680269-2017-00001
• Device Sequence Number: 1132529
• Product Code: IYN
• UDI-Device Identifier: 05704916001025
• UDI-Public: 05704916001025
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K081154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Service Personnel
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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: Other
• Device Model Number: FLEX FOCUS 800 SYSTEM
• Device Catalogue Number: 1202/UA1214
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1