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

Model Number ENSITE-DWS-01

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 289201740
• Report Number: 2184149-2022-00098
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1