MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INTEGRATED VIEWING SYSTEM, VANTAGEVIEW SYSTEM, (120VAC); DISPLAY, CATHODE-RAY TUBE, MEDICAL

Model Number	VS100001
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure with the patient on the table, the system shutdown / went black and the case was cancelled.
Additional Manufacturer Narrative
Additional information: g3, h2, h3 during field service, a faulty svdc power cable connection was replaced.Additionally, a faulty sc male fiber connector was noted on the blue fiber cable at the patch panel which was replaced.Replacement of the faulty power cable & connector resolved the issue and the system functioned as intended.This device history record was completed by a representative from avi.Based on the information provided to abbott and the investigation performed, the cause for the reported system shutdown was isolated to the power connector.

• Brand Name: INTEGRATED VIEWING SYSTEM, VANTAGEVIEW SYSTEM, (120VAC)
• 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: 11826665
• Report Number: 2184149-2021-00154
• Device Sequence Number: 4414362
• Product Code: DXJ
• UDI-Device Identifier: 05414734218412
• UDI-Public: 05414734218412
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: VS100001
• Device Catalogue Number: VS100001
• Device Lot Number: 5219987
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1