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

Model Number 100015555

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Before an ablation procedure, the amplifier was powered with no success.The calibration process failed and the amplifier remained in the orange light mode.Several configurations regarding the setup and multiple power sockets were tried in the lab with no success.The patient was already prepared for the case when the procedure was cancelled.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h6.One ensite velocity¿ system velocity amplifier was received for evaluation.Visual inspection revealed the chassis, connectors and labels appeared to have no physical damage.The amplifier passed the power on self-test with a green led status and communication was established.Review of system logs confirmed the field reported event as incomplete boot and power up errors on various boards were observed.The amplifier was power cycled numerous times, but the field reported event was unable to be reproduced.Further inspection included functional testing of the amplifier and it was verified consistent signals, current, and impedance measurements were observed.The root cause remains undetermined as the field reported event was not reproducible.

• Brand Name: ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER
• 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: 10355342
• MDR Text Key: 201336933
• Report Number: 2184149-2020-00115
• 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
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100015555
• Device Catalogue Number: 100014514
• Device Lot Number: 6765358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other