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

Model Number	100014514
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During prep for an atrial fibrillation procedure with the patient on the table, a self test issue occurred and the procedure was cancelled.While assembling the machine, the amplifier did not start properly and an orange light was displayed.Multiple restarts did not resolve the issue and the procedure was cancelled with no consequences to the patient.The procedure will be rescheduled.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3 one ensite velocity¿ amplifier was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels show signs of wear consistent with use over time.Power was applied to the amplifier and the amplifier passed power-on-self-test (post).The amplifier went status ready ¿green¿ and communicated with the test ensite computer.Evaluation of the board status showed all boards status are green indicating passing results.Evaluation of the logs revealed multiple events related to the network adaptor not passing post.This confirmed the reported symptom, however this was unable to be duplicated within investigations.The network adaptor resides upon the micro-processor (pn: (b)(6) board and was consistent with an intermittent post.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 provided to abbott and the investigation performed, the reported event was not able to be duplicated, and the root cause was consistent with an intermittent micro-processor board.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: ENSITE
• 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: 18046444
• Report Number: 2184149-2023-00218
• Device Sequence Number: 8255090
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: (01)05414734210713(21)19338165(10)8380890
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201181
• 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,Followup
• Report Date (Section B): 07/22/2024

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: 100014514
• Device Catalogue Number: 100014514
• Device Lot Number: 8380890
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 06/12/2024; 07/09/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/29/2024; 06/20/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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