MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X EP SYSTEM DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-DWS-01
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure, when the system was powered on, the luks password screen was displayed.The usb port and dvd drive were empty.The "enter" was pressed on the ensite with no resolution.The system was power cycled several times to resolve the issue.The procedure was completed without replacing the device and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
One ensite x display workstation (dws) 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.It was observed that the hostname installed was dwsx19005765.The main log-in information was not returned with the product.Hardware diagnostics revealed both the memory and the hard drive tests were successful.The reported event was not able to be duplicated.Hardware evaluation testing was successful.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 returned images, the investigation, and information provided to abbott, the reported event of power problem was confirmed, however the root cause remains undetermined.

• Brand Name: ENSITE X EP SYSTEM 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: 14053222
• Report Number: 2184149-2022-00098
• Device Sequence Number: 4766205
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202066
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: ENSITE-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 7986637
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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