MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X AMPLIFIER; Computer, diagnostic, programmable

Model Number	ENSITE-R-AMP-02
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite x amplifier was received for evaluation.For evaluation purposes, ports 3 and 4 (small form-factor pluggable / sfp) were temporarily exchanged.The amplifier was powered on and then the amplifier booted to a solid green ¿ready¿ light emitting diode (led) status.This indicated the amplifier passed the power-on-self-test (post) and then successfully communicated with the test station tracker software.The service tool was then connected, and the amplifier passed post and successfully communicated with putty.The date command was sent to the amplifier, and the amplifier returned a date and time that was set to default.This is indication that the keep alive memory of the cmos battery was interrupted.A low battery voltage may not sustain the energy required for the keep alive memory to maintain memory.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 root cause was attributed to the cmos battery that resides on the system-on-module.
Event or Problem Description
During preparation for an atrial fibrillation procedure, a communication issue occurred and the procedure was cancelled.While the patient was on the table under general anesthesia, it was reported that there was no connection between amplifier and dws; the green led was blinking.Restarted several times and changed the fiber optic two times.It was mentioned that the small green triangle at the back of the amplifier was on, usually meaning that communication is good.Additionally, a red light was visible in the fo when unplugging it.Everything from the amplifier was removed before trying to reboot.

• Brand Name: ENSITE¿ X AMPLIFIER
• 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: 20724961
• Report Number: 2184149-2024-00199
• Device Sequence Number: 17072425
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: (01)05415067034748(10)10116691
• Combination Product (Y/N): N
• Initial Reporter Country: MB
• PMA/510(K) Number: K231415
• 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
• Report Date (Section B): 11/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: ENSITE-R-AMP-02
• Device Catalogue Number: ENSITE-R-AMP-02
• Device Lot Number: 10116691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• 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: 11/18/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown