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

Model Number 100014514

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

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

Event Date 04/26/2021

Event Type  malfunction  

Event Description

During a supraventricular tachycardia procedure, the amplifier booted up with an amber light which caused a delay.Following insertion of the catheters into the patient, the amplifier booted up with an amber light.Power cycling the amplifier and/or cleaning the filter did not resolve the issue.After troubleshooting, the amplifier did not work and the procedure continued without mapping.After approximately 30-45 minutes, the amplifier was turned back on and the case was completed with no consequences to the patient.

Manufacturer Narrative

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 was powered on to a green led status which indicates the power on self-test was successful and communication was established with the test station.Review of the error logs identified several incomplete bootups for the reported date.The amplifier was power cycled several times and the field reported event was not reproducible.The amplifier consistently booted to a green led status.Further inspection confirmed functional testing of the amplifier was successful.Consistent current and impedance measurements were observed.Based on the information provided to abbott and the investigation performed, the amplifier operated as intended during the evaluation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported self test issue and subsequent delay remains unknown.

• 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: 11820462
• MDR Text Key: 251424180
• Report Number: 2184149-2021-00135
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K141050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100014514
• Device Catalogue Number: 100014514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1