MAUDE Adverse Event Report:; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2019

Event Type  malfunction  

Event Description

Patient reported to radiation oncology department for spaceoar/fiducial procedure with anesthesia.Rectal probe machine was checked and determined in working order prior to procedure by physicist.Patient was placed under anesthesia and procedure was started.When rectal probe machine was ready to be used an error message came up on screen.Physicist rebooted and checked multiple things and after many attempts machine still did not work for procedure.Patient was recovered by anesthesia and patient will need to be rescheduled for procedure.The doctor did speak with patient and daughter once recovered to make them aware procedure was not done.

• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 8627163
• MDR Text Key: 145621987
• Report Number: 8627163
• 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: 05/03/2019

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: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA