MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM; 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 03/27/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

At the beginning of the procedure, the orange lights on the amplifier did not switch to green, resulting in a cancellation.When switching the ensite cpu there was an error message stating that there was an amplifier error.Logging out and restarting both the amplifier and dws were performed several times but the issue persisted and the procedure was cancelled.The amplifier was replaced.There were no adverse patient consequences.

Manufacturer Narrative

One velocity amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels appeared to have no physical damage.The mounting hardware was secured.Normal wear and tear was observed on the exterior enclosure.No other visible anomalies were observed.When the amplifier was powered on and had timed in, it was displaying a flashing yellow led.The current source board was not seen in board status.Error logs show slot 2 power up errors in 10 of 15 log files.The failure was duplicated in the board tester.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 specifications and procedures.Based on the information provided to abbott and the investigation performed, the cause for the reported event was due to a non functional current source board.

• Brand Name: ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM
• 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: 8508474
• MDR Text Key: 141735885
• Report Number: 2184149-2019-00038
• 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: 05/24/2019

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: 100014514
• Device Lot Number: 5136194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 86