MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number 100015555

Device Problems Image Display Error/Artifact (1304); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  Injury  

Event Description

During device preparation, with the patient lying on the table administered with diazepam, the procedure was delayed one hour.An error message displayed on the amplifier that read "amplifier error.Log out and power cycle both the ensite velocity dws and amplifier before restarting.Contact sjm technical support." after several reboot attempts the amplifier booted and the procedure was continued and completed with no adverse consequences to the patient.

Manufacturer Narrative

Ac power was applied successfully to the amplifier, however a flashing amber led was displayed, indicating the amplifier did not pass the self-test.Review of the log files showed the catheter amplifier board in slot 6 had errors at channel 2.Further investigation revealed slot 6 had high resistant contacts on the relays.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: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7040385
• MDR Text Key: 92295411
• Report Number: 2184149-2017-00054
• Device Sequence Number: 1
• Product Code: DQK
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 100015555
• Other Device ID Number: 05414734210713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2011
• 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