MAUDE Adverse Event Report: BK MEDICAL HOLDING COMPANY BK3000, BK3500, BK5000 ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problems No Display/Image (1183); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

The ultrasound screen malfunctioned while the patient was asleep under general anesthesia for a transperineal biopsy prostate with a fusion procedure.The bk medical systems ultrasound screen was not showing an image.Biomedical engineering was notified and performed troubleshooting on the equipment.Biomed was unable to get the ultrasound to operate.The surgical team decided to cancel the procedure due to the device malfunction, and there was no other backup ultrasound equipment to use.The patient was on the table for about 50 minutes asleep under anesthesia and was woken up without his procedure having been done.

• Brand Name: BK3000, BK3500, BK5000 ULTRASOUND SYSTEM
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BK MEDICAL HOLDING COMPANY; 25 corporate drive; suite 230; burlington MA 01803
• MDR Report Key: 17030201
• MDR Text Key: 316211753
• Report Number: 17030201
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Male
• Patient Race: White