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

Model Number	H700096
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the workmate claris computer displayed an error message and the procedure was cancelled.The old workmate system was replaced by the new ensite x version of workmate claris.
Additional Manufacturer Narrative
Additional information: the results of the investigation were 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 error and subsequent cancellation could not be determined.
Event or Problem Description
During a procedure, the workmate claris computer displayed an error message and the procedure was cancelled.The old workmate system was replaced by the new ensite x version of workmate claris.The error message that displayed was error message: "162-system options not set.The system configuration has changed since the last boot.Addition of a hard drive, etc., or loss of power to the real time clock has occurred.Pressing f1 will record the new configuration.If this message persist, you may need to replace the onboard battery.".

• Brand Name: EP-WORKMATE¿ 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: 21995035
• Report Number: 2184149-2025-00090
• Device Sequence Number: 20911085
• Product Code: DQK
• UDI-Device Identifier: 05415067000965
• UDI-Public: (01)05415067000965(10)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: H700096
• Device Catalogue Number: H700096
• Was Device Available for Evaluation?: No
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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