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

Model Number EE3000

Device Problem Communication or Transmission Problem (2896)

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

Event Date 10/18/2021

Event Type  malfunction  

Event Description

During a 3d case, a communication issue occurred and the procedure was cancelled.Following mapping of the left ventricle, before the first ablation, the ensite stopped and connection with the amplifier was lost.The dws and amplifier were reset, however the amplifier still had a flashing orange light and the procedure was cancelled.

Manufacturer Narrative

One ensite velocity¿ amplifier was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels were free of physical damage.Power was applied to the amplifier and the amplifier did not pass power-on-self-test (post).The amplifier went status not-ready blinking ¿amber¿ and communicated with the test ensite computer.Evaluation of the board status showed the electro-cardiogram (ecg) board was not available.The error logs had temperature and voltage out of range conditions which confirms the reported symptom.The reported event was able to be duplicated by power sequencing and evaluation of the logs.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 confirmed, and the root cause was attributed to the electro-cardiogram board in slot 4.

• Brand Name: ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM
• Type of Device: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12650479
• MDR Text Key: 279985804
• Report Number: 2184149-2021-00323
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K160187
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EE3000
• Device Catalogue Number: 100014514
• Device Lot Number: 5265756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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