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

Model Number	VS100003
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure with the patient was on the table and intubated, the system lost all video after approximately 20-30 seconds.Troubleshooting did not resolve the issue and the procedure was cancelled with no consequences to the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h4.The product was not returned however, a replacement "monitor" was sent, but is unknown if it resolved the issue.The device history record was reviewed and found to be complete.Based on the information received, the cause of the reported display issue and subsequent cancellation remains unknown.If the issue persists it is recommended to return the product for evaluation.

• Brand Name: VANTAGEVIEW SYSTEM
• 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: 11965832
• Report Number: 2184149-2021-00194
• Device Sequence Number: 11829346
• Product Code: DXJ
• UDI-Device Identifier: 05415067010841
• UDI-Public: 05415067010841
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: VS100003
• Device Catalogue Number: VS100003
• Device Lot Number: 6258246
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1