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

Model Number EE3000

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During preparation with the patient on the table, the amplifier was booted up, displayed a flashing amber light and the case was cancelled.Multiple reboots were attempted, the air filter was cleaned, and a second outlet was attempted.The issue was not able to be resolved and the procedure was aborted and cancelled.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Ac power was then applied, and the returned amplifier failed to successfully complete the post (power on self-test) and the system status light remained amber.Additional analysis isolated the root cause of the reported issue to an incomplete system calibration of the catheter amplifier pca (printed circuit assembly) located in the slot 11 position.Failure to power up slot 11 was also confirmed within the system log files.The system was recalibrated, and normal functionality was restored to the system.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause of the reported event has been isolated to an incomplete system calibration which resulted in the loss of the catheter amplifier board at the slot eleven location.

• 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
• MDR Report Key: 10622938
• MDR Text Key: 209775337
• Report Number: 2184149-2020-00166
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EE3000
• Device Catalogue Number: EE3000
• Device Lot Number: 7052735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other