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

Model Number	100149280
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, there was a failure to power up issue with the ensite velocity display workstation that resulted in a cancellation of the procedure.When the patient was lying on the hospital bed, it was noted that the ensite display workstation could not be turned on normally.Repeated reboots were ineffective and the power button on the ensite velocity display workstation flashed red.There was no spare machine, and the procedure was cancelled with no adverse consequences to the patient.The procedure was performed for the same patient the following day and was completed successfully.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the power up issue were identified.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.
Additional Manufacturer Narrative
One ensite velocity¿ display workstation (dws) 7 was received for evaluation.Visual inspection revealed the chassis and labels show wear consistent with use over time.Visual inspection of the front panel ports identify the optica disk drive was physically damaged.Internal visual inspection revealed an ingress of foreign materials (dust).The dws device accessories were connected, power was applied and the dws passed the power-on-self-test (post).As the dws was loading, the internal fans sped up to maximum.This issue was isolated to the secondary processor board (by means of removal).The dws loaded the operating system then ensite application main log-in screen loaded successfully.As the service account was logged in, a ¿resource error¿ appeared.The main memory was identified on the motherboard, which was isolated to the ram (availability) on the secondary processor board.It was observed that the software, entitlement was issued to hostname: dwsg703656 which matches all labeling.The collect logs were pulled and inspected.The ¿resource¿ pop-up message was related to the secondary processor not being available for the internal resources.It was noted when bios was inspected, the device had ¿don¿t care¿ in its identifications, which were removed by investigations.Loss or intermittent secondary processor can potentially cause post conditions confirming the reported symptom.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.The reported event was able to be confirmed by power sequencing and resource checks.Based on the investigation and information provided to abbott, the reported event was not able to be duplicated, however the root cause was attributed to the secondary processor board.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19623779
• Report Number: 2184149-2024-00112
• Device Sequence Number: 6434306
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: (01)05415067014573(10)6681374
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201181
• 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): 05/20/2025

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: 6681374
• 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: 06/15/2024
• Supplement Date Received by Manufacturer: 08/06/2024; Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/26/2024; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2018
• 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