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

Model Number 100052392

Device Problem Unexpected Shutdown (4019)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During an atypical right atrial flutter ablation procedure, the dws shut down and the procedure was cancelled.After verifying the connections, replacing the connectors, and verifying the power conditioner was functioned properly and plugging the power supply into different outlets, the dws would only remain on for a few seconds.The patient was sedated and catheters were placed in the heart prior to cancelling the procedure.The procedure will be rescheduled.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

The results of the investigation are inconclusive since the customer has not yet decided to return the unit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported shut down and subsequent procedure cancellation could not be determined.

• Brand Name: ENSITE VELOCITY VELOCITY DWS5.1 CHASSIS
• 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: 11020013
• MDR Text Key: 226321405
• Report Number: 2184149-2020-00232
• Device Sequence Number: 1
• Product Code: DQK
• 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: 02/01/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other