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 Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

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 the procedure, the amplifier would display an amber light and the procedure was cancelled.Troubleshooting was attempted with no resolution.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for investigation.When the amplifier was powered on and had timed in, it was displaying a solid green led.Error logs and post history show the catheter amplifier board in slot 6 has failed temperature sensors several times.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 provided to abbott and the investigation performed, the root cause of the amber light and subsequent procedure cancellation was isolated to the catheter amplifier board in slot 6.

• 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: 9289844
• MDR Text Key: 165395383
• Report Number: 2184149-2019-00218
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100014514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other