MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM DWS6 VELOCITY V.4.0.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	100102249
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the svt procedure, it was noted that the vertical screen prompted that the 1920 * 1200 resolution could not be supported which caused delays to treatment.After restarting the host computer, both displays would not display normally.After plugging and unplugging the graphics card, memory module and hard disk, the issue still did not resolve.After replacing the standby host computer and monitor, the issue was resolved and the operation proceeded normally.The procedure was completed without patient consequences.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.
Additional Manufacturer Narrative
Additional information: b5, d9, d10, g3, g6, h2, h3, h6.One ensite velocity¿ system dws6 velocity was received for investigation.Based on the information provided to abbott and the investigation performed, the root cause of the reported cannot be conclusively determined as no hardware related issues were identified during the evaluation period.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
Event or Problem Description
Related manufacturing reference: 2184149-2023-00021.During the svt procedure, it was noted that the vertical screen prompted that the 1920 * 1200 resolution could not be supported which caused delays to treatment.After restarting the host computer, both displays would not display normally.After plugging and unplugging the graphics card, memory module and hard disk, the issue still did not resolve.After replacing the standby host computer and monitor, the issue was resolved and the operation proceeded normally.The procedure was completed without patient consequences.

• Brand Name: ENSITE VELOCITY¿ SYSTEM DWS6 VELOCITY V.4.0.1
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16378385
• Report Number: 2184149-2023-00020
• Device Sequence Number: 6081784
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 100102249
• Device Catalogue Number: EE3000
• Device Lot Number: 5860383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLAT PANEL FOR ENSITE VELOCITY¿
• Patient Sex: Unknown