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

Model Number	ENSITE-DWS-1.1
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, the ensite x amplifier was not communicating with the ensite x display workstation resulting in cancellation of the procedure.A second new fiber was attempted, restarted the system, reseated the sfp connections, disconnected the ethernet data port with no resolve.The ensite x amplifier was replaced, but there was still no communication.The sfp were exchanged with a second amplifier, but the issue was not resolved.The ensite x display workstation was then alleged to be the issue.The case was cancelled with a patient on the table.There was no patient harm.
Additional Manufacturer Narrative
One ensite x display workstation (dws) was received.The dws was connected with a known good ensite x amplifier and lc/lc fiber optic cable.The reported symptom was duplicated as the amplifier would not communicate with the dws.The small form-factor pluggable receiver (sfp) was exchanged with a known good sfp and still no communications were established.Based on the information provided to abbott and the investigation performed, the root cause remained undetermined as no further evaluation could be performed.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.
Additional Manufacturer Narrative
One ensite x display workstation (dws) was received.The dws was connected with a known good ensite x amplifier and lc/lc fiber optic cable.The reported symptom was duplicated as the amplifier would not communicate with the dws.The small form-factor pluggable receiver (sfp) was exchanged with a known good sfp and still no communications were established.Based on the information provided to abbott and the investigation performed, the root cause was identified to the internal software configuration files of the hard disk drive.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.

• Brand Name: ENSITE¿ X DISPLAY WORKSTATION
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18698059
• Report Number: 2184149-2024-00030
• Device Sequence Number: 18225722
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: 05415067037725
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K212061, K22
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENSITE-DWS-1.1
• Device Lot Number: 8275725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 02/29/2024; Not provided
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/11/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown