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

Model Number VS100005

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  Injury  

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 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
• Type of Device: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10366882
• MDR Text Key: 201672226
• Report Number: 2184149-2020-00112
• Device Sequence Number: 1
• Product Code: DXJ
• UDI-Device Identifier: 05415067010865
• UDI-Public: 05415067010865
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VS100005
• Device Catalogue Number: VS100005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1