MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE¿ CLARIS¿ COMPUTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700977
Medical Device Problem Codes	Communication or Transmission Problem (2896); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One claris display workstation was received for evaluation.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to internal network card was disabled (configuration setting) by windows.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported communication and output issues, and subsequent cancellation were identified.
Event or Problem Description
During an atrial fibrillation procedure, the computer was having communication and output issues which resulted in a cancellation of procedure.While patient was on the table, an "amplifier is disconnected" message and "unable to open port 44.44.44.90" message appeared.The fiber optic cable, media converter, and amplifier were all swapped out, but with no resolution.The computer was replaced, and the issue was resolved.However, due to how long troubleshooting took, the procedure was aborted and rescheduled.

• Brand Name: WORKMATE¿ CLARIS¿ COMPUTER
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20396731
• Report Number: 2184149-2024-00171
• Device Sequence Number: 6479450
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: (01)05415067009777(10)6401314
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K210392
• 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
• Report Date (Section B): 10/24/2024

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: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 6401314
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2018
• 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