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

Model Number	100129557
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, the system was unable to enter the menu selection mode and restarting was invalid causing a delay.Another system was obtained from a different hospital which took 30 minutes.The procedure was then completed with no consequences to the patient.
Additional Manufacturer Narrative
One ensite velocity¿ display workstation (dws) was received for evaluation.Visual inspection revealed the front panel ports, and labels show signs of wear consistent with use over time.Internal visual inspection revealed all connectors were seated securely and routed correctly.The dws device accessories were connected along with power.Power was applied and the dws passed the power-on-self-test (post).As the dws tried to load the operating system, a display message appeared: ¿welcome to emergency mode¿¿, then listed file system errors and caused the system to be forced off.The hardware diagnostic tests were run and were successful.The hostname of the disk drive matches the chassis hostname label: (b)(6).Temporary replacement of the hard disk drive solved the post condition.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 reported event was able to be duplicated by power sequencing, and the root cause was attributed to soft data (file systems) related to the operating system that were modified on the hard disk drive.

• Brand Name: ENSITE VELOCITY¿ DWS7 DISPLAY WORKSTATION
• 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: 17298846
• Report Number: 2184149-2023-00142
• Device Sequence Number: 20585243
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160187
• 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): 10/20/2023

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: 100129557
• Device Catalogue Number: EE3000
• Device Lot Number: 8307566
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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