MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-DWS-1.1

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, there was not output from the remote video and the procedure was cancelled.The dws was rebooted which restored remote video, but then there were amplifier communication issues.After restarting both the dws and amplifier several times, communication was not established, and the case was cancelled.The patient was rescheduled for oct.6.The device is still being used at the facility.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported output issue remains unknown.

• Brand Name: ENSITE¿ X DISPLAY WORKSTATION
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17816384
• MDR Text Key: 324229840
• Report Number: 2184149-2023-00194
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: 05415067037725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: ENSITE-DWS-1.1
• Device Lot Number: 8877490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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 Sex: Male