MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VANTAGEVIEW, 16 CHANNEL SYSTEM, 120V; DISPLAY, CATHODE-RAY TUBE, MEDICAL

Model Number	VS100005
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed.Based on the information received and troubleshooting performed in the field, switching the input ports resolved the issue.The cause of the display issue and subsequent procedure delay remains unknown.
Event or Problem Description
During the procedure, when attempting to change video sources and switch presets on the system via the tablet, the source would not appear resulting in a significant delay in procedure.The server rack was rebooted, the ups was reset and the router was reset.Following this reset, everything initially displayed on the tablet as expected but three more output sources were lost.Since this occurred during the procedure, the output sources could not be power-cycled.Secondary monitors were used to resolve the issue and the procedure was completed successfully.There were no adverse consequences to the patient due to the delay.

• Brand Name: VANTAGEVIEW, 16 CHANNEL SYSTEM, 120V
• Common Device Name: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10366882
• Report Number: 2184149-2020-00112
• Device Sequence Number: 16898423
• Product Code: DXJ
• UDI-Device Identifier: 05415067010865
• UDI-Public: 05415067010865
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VS100005
• Device Catalogue Number: VS100005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1