MAUDE Adverse Event Report: BK MEDICAL APS BKSPECTO ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 1300-S5

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 05/20/2022

Event Type  malfunction  

Event Description

Ultrasound was in the room and had been used prior to this surgery and worked fine.Patient came to room, was put under anesthesia and was asleep.Ultrasound machine had an error code.Rep and tech support contacted.This was an unrecoverable code.Or case then cancelled due to equipment malfunction.Patient woke up and taken to pacu.No harm to the patient.Procedure to be done: transperineal prostate biopsy.Procedure cancelled.Went to the vendor.Returned to service by vendor.

• Brand Name: BKSPECTO ULTRASOUND SYSTEM
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BK MEDICAL APS; 25 corporate drive suite 230; burlington MA 01803
• MDR Report Key: 15502864
• MDR Text Key: 300770908
• Report Number: 15502864
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2022

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
• Device Model Number: 1300-S5
• Device Catalogue Number: 1300-S5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male