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

Model Number	H700150
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation for an atrial fibrillation procedure, a communication issue occurred causing a delay.While the patient was on the table, the workmate amplifier connected on start-up but disconnected after approximately 10 minutes.The amplifier was restarted, but the same issue occurred.The media converter and fiber optic cable were replaced which did not resolve the issue.The amplifier then reconnected on its own.Troubleshooting delayed the start of the procedure by one hour.The procedure was completed without patient consequences.
Additional Manufacturer Narrative
Correction d1: workmate¿ claris¿ media converter.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported communication issue and subsequent delay remains unknown.

• Brand Name: WORKMATE¿ CLARIS¿ MEDIA CONVERTER
• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20134523
• Report Number: 2184149-2024-00150
• Device Sequence Number: 17961330
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: (01)05415067001504(10)10180065
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup,Followup
• Report Date (Section B): 11/08/2024

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: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 10180065
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 11/08/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/24/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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