MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY DWS7 V.5.0.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	100149280
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer report numbers: 3005334138-2021-00089, 2184149-2021-00043.During an a-flutter ablation procedure, the amplifier would blink yellow when coming on ablation.The amplifier error message "logout and restart amplifier and system" was noted.The dws, generator and amplifier were all power cycled but the issue remained.The catheter was replaced and cryo was used to continue the procedure.Upon further inspection, bent pins were noted on the navx connector on the amplifier.In addition, the ensite dws secondary monitor output (via display port) was not working.The secondary image was unable to come up on siemens monitor.The display port dongle was replaced twice, in addition to replacing the dvi to dvi cable, but that did not resolve the issue.The set up was connected on the primary monitor port and the image was able to be displayed.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One ensite velocity¿ dws7 was received into the lab for analysis.Ac power was applied to the velocity display workstation which successfully passed the initial hardware self-test prior to the launch of the ensite application.Video display was confirmed on both the primary and remote monitor displays.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.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, the root cause of the reported event cannot be conclusively determined based on the device returned.No hardware related issues were identified with the returned product during the evaluation period.

• Brand Name: ENSITE VELOCITY DWS7 V.5.0.1
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11411018
• Report Number: 2184149-2021-00044
• Device Sequence Number: 14406960
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 03/12/2021

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: 100149280
• Device Catalogue Number: EE3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE AMPLIFIER; TACTICATH SE