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 05/21/2020

Event Type  Injury  

Manufacturer Narrative

One ensite velocity¿ system amplifier was returned for investigation.Power was applied to the returned amplifier which successfully completed the post (power on self-test) and the system status light changed to green.System log files were reviewed which revealed both voltage out of range and temperature out of range errors for the catheter amplifier board in the slot thirteen location.Review of the system log files and current board status revealed the catheter amplifier board in the slot 13 location was not active with multiple faults stored.Based on the information provided to abbott and the investigation performed, the root cause of the self-test issue and subsequent procedure cancellation was isolated to abnormal functionality of the catheter amplifier pca in the slot thirteen location.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.

Event Description

During the procedure, the amplifier would not boot and displayed an amber flashing light.Multiple reboots were attempted with no resolution and the procedure was cancelled.Multiple power receptacles were attempted and the air filter was cleaned but the light remained amber.There were no adverse consequences to the patient due to the cancellation.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10132835
• MDR Text Key: 194472525
• Report Number: 2184149-2020-00076
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/09/2020

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: 100014514
• Device Catalogue Number: 100014514
• Device Lot Number: 7025155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other