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

Model Number	VS100005
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to the ventricular tachycardia (vt) procedure, after the patient was prepped, the maclab live signal was not displaying on the vantageview monitor.Rebooting the rack and the power converter did not resolve the issue.A media convertor was found to be the issue.The patient was prepped and procedure was cancelled.There were no adverse patient consequences.
Additional Manufacturer Narrative
The product was not returned however, a replacement was sent, but is unknown if it resolved the issue.This device history record was completed by a representative from avi.Everything passed vendor and manufacture testing.Based on the information received, the cause of the reported incident could not be conclusively determined.If the issue persists it is recommended to return the product for evaluation. .

• Brand Name: VANTAGEVIEW, 16 CHANNEL SYSTEM, 120V
• Common Device Name: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12263537
• Report Number: 2184149-2021-00240
• Device Sequence Number: 5002124
• Product Code: DXJ
• UDI-Device Identifier: 05415067010865
• UDI-Public: 05415067010865
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: VS100005
• Device Catalogue Number: VS100005
• Device Lot Number: 7720196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1