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 11/19/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.

Event Description

Prior to the procedure, the amplifier started the self-test at start-up, but it was not completed successfully.The red light was lit permanently or flashing.The amplifier was power cycled, disconnected from the power, and the cables were reconnected, however resolution was not found., the problem could not be solved.The patient had been prepped and the procedure was cancelled.There were no adverse patient consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported startup issue and subsequent cancellation could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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: 9382948
• MDR Text Key: 168214109
• Report Number: 2184149-2019-00236
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100014514
• Device Catalogue Number: 100014514
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other