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

Model Number ENSITE-AMP-02

Device Problem Communication or Transmission Problem (2896)

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

Event Date 10/14/2021

Event Type  malfunction  

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.Based on the information received, the cause of the reported incident could not be determined.

Event Description

During an atrial flutter (afl) procedure, the dws lost connection with the amplifier and an error message appeared stating "¿an amplifier hardware error has been detected.Power down and restart the amplifier." and the amplifier displayed a flashing orange light.The amplifier was powered down and restarted, but the light was still flashing orange.The dws and the amplifier were powered down and restarted, the issue was resolved at that time and the study was resumed.However, the issue occurred another 3-4 times throughout the case requiring a restart each time.There were no adverse consequences to the patient, but the system could not be used during this time and the procedure was completed using fluoroscopy.A procedure delay occurred due to this issue.

Manufacturer Narrative

One ensite x amplifier was received for evaluation.Visual inspection revealed the front ports, rear ports, and chassis were free of physical damage.The amplifier was powered on and the amplifier booted to a flashing green led status.This indicated the amplifier passed the power-on-self-test (post) and communication was established.The field reported event was then confirmed as the amplifier eventually displayed a flashing amber led status.A remote connection to the amplifier¿s terminal was established, and an evaluation of the post log identified the cardiamp board at slot 0 experienced a self-test failure.The power management bus check identified abnormal current output.The field reported event was confirmed.The power on self-test was not successful during the evaluation.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 isolated to a non-functional cardiamp board.

• Brand Name: ENSITE X EP SYSTEM AMPLIFIER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 12688199
• MDR Text Key: 278092660
• Report Number: 2184149-2021-00320
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• 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 Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8058381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2021
• 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