MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH UROSKOP OMNIA MAX; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10762473

Device Problem No Display/Image (1183)

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

Event Date 06/20/2019

Event Type  malfunction  

Event Description

Event summary from user: readied room, positioned and prepped patient then plugged equipment in.Screen did not function properly and there were no xray or scope/camera images present.Transferred patient safely to another operating room to perform procedure.No harm to patient.Manufacturer help desk notified including biomed.Patient impact: after the induction of mac anesthesia the patient was positioned on the table.The x-ray portion of the table was unable to be activated and for this reason the patient was transferred to a second room while under mac anesthesia.No harm to the patient.Symptoms reported: bed is moving but not displaying anything on the monitors.Corrective action: video manager failed to boot properly and would not communicate with the system, nor would it produce a display on any monitor.Replaced the video manager and configured it, and saved a backup.System check: tests, checks, inspections and/or repairs have been performed in accordance with the specific service task.The system is functioning properly based upon completion of the specific service task undertaken by siemens.Manufacturer response for urology or table, uroskop omnia max (per site reporter).Symptoms reported: bed is moving but not displaying anything on the monitors.Corrective action: video manager failed to boot properly and would not communicate with the system, nor would it produce a display on any monitor.Replaced the video manager and configured it, and saved a backup.System check: tests, checks, inspections and/or repairs have been performed in accordance with the specific service task.The system is functioning properly based upon completion of the specific service task undertaken by siemens.

• Brand Name: UROSKOP OMNIA MAX
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 8955843
• MDR Text Key: 156296525
• Report Number: 8955843
• Device Sequence Number: 1
• Product Code: JAA
• 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: 06/25/2019,06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10762473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 94