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	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
A red tint was noted on the left half of the screen and the tablet was booting up to a (b)(6) error message.The patient was under general anesthesia at the time and troubleshooting caused a clinically significant delay.The issue was eventually resolved and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Field service was performed and after replacing all the optics transmitters, the discolored display was resolved.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 in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the cause for the reported event was the optics transmitter.

• 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: 9294949
• Report Number: 2184149-2019-00213
• Device Sequence Number: 607527
• Product Code: DXJ
• UDI-Device Identifier: 05415067010865
• UDI-Public: 05415067010865
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VS100005
• Device Lot Number: 6968676
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other