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

Model Number 100014514

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received for evaluation.Power was applied to the returned amplifier and the system status light changed from amber to green after several minutes.A review of the system log files revealed multiple logs where the file was void of all data.During the log file review the system status light changed from green to off which confirmed the reported issue.Communication with the returned amplifier was successfully maintained during the system status light fluctuation.Based on the information provided to abbott and the investigation performed, the root cause of the field reported communication issue and subsequent delay in procedure was isolated to intermittent abnormal functionality of the micro-controller.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Further information regarding the event were requested but not received.

Event Description

During the procedure, amplifier disconnected from the dws.Upon rebooting the status light would go from amber to green, however would disconnect again.The case was completed with a non-abbott system, however there was as clinically significant delay in the procedure.The patient was intubated and the equipment had to be disassembled, and a period of 30-40 minutes occurred before the case could continue.

• 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. (AF-ST. PAUL); 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: 8896323
• MDR Text Key: 154393760
• Report Number: 2184149-2019-00147
• 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: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• 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: 6649951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other