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

Model Number	H700977
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During prep with the patient on the table, a communication issue occurred and the procedure was cancelled.The media converter, power supply for the media converter, fiber and ethernet cables were exchanged and the issue remained.The amplifier was then disconnected 3 times which did not resolve the issue and the procedure was cancelled.
Additional Manufacturer Narrative
One claris display workstation was received for evaluation.Visual inspection revealed normal wear and tear on the external chassis.Power was applied to the dws, and the dws passed the power-on-self-test (post).The dws loaded the operating system, then the workmate claris application successfully.Communication with a test claris amplifier was confirmed and no anomalies were noted.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 provided to abbott and the investigation performed, the reported communication issue and subsequent cancellation remains unknown as it could not be duplicated.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h11.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: WORKMATE¿ CLARIS¿ COMPUTER
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18048329
• Report Number: 2184149-2023-00219
• Device Sequence Number: 12619323
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: (01)05415067009777(21)15115432(10)4799951
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151911
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 8572796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/25/2024; 06/11/2024; 07/10/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/25/2024; 06/20/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2014
• 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