MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY¿ VELOCITY DWS5.1 CHASSIS; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100052392

Device Problem Application Program Problem (2880)

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

Event Type  malfunction  

Manufacturer Narrative

Abbott was unable to evaluate the product involved in this incident since neither the electronic files from the reported event date or actual device were returned for analysis.Based on the information received, the cause of the reported incident could not be determined.

Event Description

During an atrial fibrillation procedure, the computer unexpectedly shutdown multiple times and due to such, the procedure was cancelled.Following the transseptal puncture and system validation, the computer unexpectedly shutdown multiple times and each time it was started again, the issue reoccurred.The procedure was cancelled and rescheduled for a future date where it was successfully completed with a replacement computer.There were no adverse consequences to the patient.

• Brand Name: ENSITE VELOCITY¿ VELOCITY DWS5.1 CHASSIS
• 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: 12787131
• MDR Text Key: 280587436
• Report Number: 2184149-2021-00336
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K172396
• 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
• Report Date: 11/10/2021

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: 100052392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2021
• Initial Date FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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