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

Model Number	ENSITE-SYSTEM-201
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, an unexpected shutdown occurred which delayed the procedure.Using navx mode v3.0.1, when mapping, creating and editing model, the system became slow and the dws shut down without any alerts being displayed.After shutting down, the red light on the dws's power button lit up three times and the beep sounded, which occurred repeatedly.The power outlet location was changed, and it was rebooted.Since it was rebooted successfully, the procedure continued, but under the same circumstances, this time it shut down without slowing down.The dws rebooted by disconnecting everything other than the power supply and restarting it, and the procedure continued.When the procedure resumed and rf delivery was performed, it shut down again.It was rebooted a third time the same way it was the second time.However, it did not reboot so fluoroscopic images and the recording system were used to check the location and effect of the rf delivery.The procedure was completed without replacing the ensite x with no consequences to the patient.
Additional Manufacturer Narrative
One ensite x display workstation (dws) z4 was received for evaluation.Visual inspection revealed the front panel ports, and labels were free of physical damage.Internal visual inspection showed that all cables were secure and without pinch.The dws device accessories were connected along with power.Power was applied and the dws displayed an error message ¿928 fatal pcie error¿ on slot0¿.This is a power-on-self-test (post) symptom identified against the serial card installed on slot 0 of the motherboard.It was noted that 3 audible error beeps also relate to a hardware point, per the hewlett packard technical guide.Both symptoms are related and identify the serial card to be the cause.The device was left in the error state which the display workstation auto-powered down, duplicating the reported symptom.When the device came back up, the slot 0 error did repeat.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 confirmed, and the root cause was attributed to the serial card installed in slot 0 of the motherboard.

• Brand Name: ENSITE¿ X SYSTEM
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19165098
• Report Number: 2184149-2024-00079
• Device Sequence Number: 7324348
• Product Code: DQK
• UDI-Device Identifier: 05415067046666
• UDI-Public: (01)05415067046666(10)10005806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221213
• 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): 07/02/2024

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-SYSTEM-201
• Device Catalogue Number: ENSITE-R-DWS-2.0.1
• Device Lot Number: 10005806
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown