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 05/04/2020

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 was requested but not received.

Event Description

During a procedure, the amplifier was unable to start due to a self test issue and the procedure was cancelled.The patient was in the room and attached to the ensite patches, and the amplifier continued to flash orange.The procedure was cancelled.

Event Description

The patient was stable with no patient consequences.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for analysis.Ac power was then applied, and the returned amplifier failed to successfully complete the post (power on self-test) and the system status light remained amber.Additional analysis isolated the root cause of the reported issue to an incomplete system calibration of the catheter amplifier pca (printed circuit assembly).The board indicated does not appear in the active board status due to the uncompleted calibration.Based on the information provided to abbott and the investigation performed, the root cause of the reported self test issue and subsequent cancellation has been isolated to an incomplete system calibration which resulted in the loss of the catheter amplifier board at the slot ten location.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: 10081050
• MDR Text Key: 191763349
• Report Number: 2184149-2020-00070
• 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,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other