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

Model Number 100015555

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Prior to the procedure, the amplifier displayed an orange light and the procedure was cancelled.The procedure was rescheduled.The patient was prepared and in the room.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for investigation.The field reported event was confirmed as the amplifier was powered on and did not pass the power on self-test (post) with an amber led status.Communication was established with the test station and review of the error logs and board status verified ¿imp post¿ failure on cath amp board on slot 8.The root cause of the reported self-test and subsequent procedure cancellation was isolated to cath amp board on slot 8.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.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 self-test issue and subsequent procedure cancellation could not be determined.

• 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: 8915026
• MDR Text Key: 155025619
• Report Number: 2184149-2019-00150
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• 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,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100015555
• Device Lot Number: 6755770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 10/16/2019; 11/25/2019
• Supplement Dates FDA Received: 10/22/2019; 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other