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

Model Number	ENSITE-DWS-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial tachycardia procedure, the amplifier and dws were not communicating which caused a delay in the procedure.The ensite x was set up and the amplifier and the dws were switched on.Everything was working, but the system warned that the field frame was not connected.The amplifier was switched off, the field frame was connected, and the amplifier was switched on again.The amplifier and dws were rebooted a few times, everything on the front of the ensite x was unplugged, and the optic fiber was replaced with no resolution.The green led was still flashing after a successful auto-test.The ensite x was switched off, the power cord was exchanged, the magnetic field frame was unplugged, and the dws was turned off.The dws was then restarted, and the amplifier was turned on.However, the green light was still blinking.Everything was then unplugged and switched off.The three small dongles that connect the tactisys to the ensite x, ampere to ensite x, and dws to ensite x were removed.The ensite x and dws were then restarted, which resolved the issue.The connection was successful, and the green light was no longer blinking.The procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
Corrected information: b5, d1, d3, d4, d9 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 communication issue could not be determined.
Event or Problem Description
During the atrial tachycardia procedure, the amplifier and dws were not communicating which caused a delay in the procedure.The ensite x was set up and the amplifier and the dws were switched on.Everything was working, but the system warned that the field frame was not connected.The amplifier was switched off, the field frame was connected, and the amplifier was switched on again.The amplifier and dws were rebooted a few times, everything on the front of the ensite x was unplugged, and the optic fiber was replaced with no resolution.The green led was still flashing after a successful auto-test.The ensite x was switched off, the power cord was exchanged, the magnetic field frame was unplugged, and the dws was turned off.The dws was then restarted, and the amplifier was turned on.However, the green light was still blinking.Everything was then unplugged and switched off.The three small dongles that connect the tactisys to the ensite x, ampere to ensite x, and dws to ensite x were removed.The ensite x and dws were then restarted, which resolved the issue.The connection was successful, and the green light was no longer blinking.The procedure was completed with no adverse patient consequences.The fiber optic cable was found to be bent and was exchanged, but the issue persisted.Following further troubleshooting the issue was isolated to the display workstation as exchanging the device resolved the issue.
Additional Manufacturer Narrative
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.No capa is required; the root cause of the reported issue could not be confirmed to be a manufacturing, design, or quality system related occurrence.Based on the information received, the cause of the reported communication issue and subsequent delay remain unknown.

• Brand Name: ENSITE X EP SYSTEM DISPLAY WORKSTATION
• 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, 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: 15580540
• Report Number: 2184149-2022-00247
• Device Sequence Number: 15070552
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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-R-AMP-02
• Device Lot Number: 7896749
• Was Device Available for Evaluation?: No
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 12/02/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/02/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female