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

Model Number	100149280
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi information (d4) and 510k (g3) are not provided within this report as this product (model 100149280) is an ous configuration not available in the us and is therefore not referenced in the gudid database.
Event or Problem Description
During an atrial fibrillation procedure, the dws did not boot normally and another was borrowed which took 3 hours.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6.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.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported issue booting up and subsequent delay remains unknown.
Event or Problem Description
Additional information confirmed this event occurred during device preparation without involving the patient.
Event or Problem Description
During an atrial fibrillation procedure, the dws did not boot normally which caused a delay as another dws was borrowed which took 3 hours.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One ensite velocity¿ display workstation was received for evaluation.The dws device accessories were connected along with power.Power was applied and the dws passed the power-on-self-test (post).The dws loaded the operating system successfully then ensite application main log-in screen loaded successfully with no errors which includes the local and remote monitor (using the displayport).The reported event was not able to be duplicated.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.Based on the investigation and information provided to abbott, the cause of the reported power issue and subsequent delay could not be determined.

• Brand Name: ENSITE VELOCITY¿ DWS7 V.5.0.1
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20646278
• Report Number: 2184149-2024-00190
• Device Sequence Number: 12639007
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: (01)05415067014573(10)7193501
• 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,Followup
• Report Date (Section B): 05/08/2025

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: 100149280
• Device Lot Number: 6713142
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 05/07/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/28/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• 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
• Patient Sex: Unknown