MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE¿ CLARIS¿ AMPLIFIER; Computer, diagnostic, programmable

Model Number	H700169
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One workmate¿ claris¿ display plus amplifier was received for analysis.The returned workmate claris amplifier was powered on and successful communication was established with the test standard workmate claris computer.However, after a short period of time, the communication dropped, and an error ¿amplifier disconnected¿ message was received on the live screen of the workmate claris system indicating that the communication between the workmate claris system and the amplifier terminated unexpectedly.It was verified the network adaptor on the single board computer (sbc) was non-functional.The sbc was temporarily replaced with a known-good unit and functionality was restored as communication was established.Based on the information provided to abbott and the investigation performed, the reported event was confirmed.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.
Event or Problem Description
During an atrial flutter procedure there were communication issues with the workmate claris amplifier, resulting in a delay.The workmate claris system was powered on and off four times to resolve the issue.There were no adverse consequences to the patient.

• Brand Name: WORKMATE¿ CLARIS¿ AMPLIFIER
• 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: 19630631
• Report Number: 2184149-2024-00108
• Device Sequence Number: 17915527
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: (01)05415067001696(10)9033904
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: H700169
• Device Catalogue Number: H700169
• Device Lot Number: 9033904
• 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: 06/07/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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