MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X AMPLIFIER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number ENSITE-AMP-02

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

During a wolff-parkinson-white procedure, there was an error on the ensite x amplifier resulting in a delay.An orange blinking light and a message saying "an amplifier hardware error has been detected.Power down and restart the amplifier.Contact abbott technical service if the problem persists" appeared on the dws screen.All troubleshooting procedures did not resolve the issue.Every time the ensite x amplifier was rebooted, it ran properly for few minutes and then the issue appeared again.The procedure finished with no consequences for the patient.But it caused a prolongation of 30 minutes of the procedure.

Manufacturer Narrative

One ensite x amplifier was received for evaluation at tech center.Visual inspection revealed the rear ports and chassis show signs of wear consistent with use over time.Visual inspection of the front panel ports revealed that the port 7 connector was missing its guidepost.It was also noted that the fan filter was clogged and there was evidence of an ingress of foreign materials (dust) throughout the amplifier.For evaluation purposes the port 3 and port 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 intra-cardiac (ic) test was performed and was successful.The amplifier was left on for an extended amount of time, and it was noted that an error condition happened related to temperature for slot 1 and 2.Tracker eventually declared it as an over temperature condition but from a cause related to (internal chassis) heat (air flow).After cleaning the air filter, the amplifier had no observed failures.When the device was warm, a reboot was initiated and a nios slot 0 error was observed, which duplicated the reported symptom.It was noted that the temperature of the internal boards will eventually shut down automatically if enough air flow is prevented to allow adequate cooling of the internals.This is why there is a recommendation to clean the air filter periodically.The field reported event was able to be duplicated by warm cycling.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to the cardiamp board in slot 0.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.

• Brand Name: ENSITE¿ X AMPLIFIER
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18441664
• MDR Text Key: 331872598
• Report Number: 2184149-2023-00255
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K231415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-AMP-02
• Device Lot Number: 8174705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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