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

Model Number	H700124
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The logs files submitted confirm the occurrence of the reported event, however based on the product not being returned, the root cause cannot be conclusively determined.
Event or Problem Description
During an atrial fibrillation ablation procedure, the workmate claris would keep on starting a new case and restarting the log which resulted in a prolonged procedure.Multiple troubleshooting efforts were attempted, but the issues remained.Although the patient experienced a prolonged procedure with extended sedation, there were no adverse consequences to the patient and the procedure was still completed.Further troubleshooting at a later time was able to resolve the issues and the system is functioning as intended.

• Brand Name: WORKMATE CLARIS SYSTEM DISPLAY PLUS
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11862740
• Report Number: 2184149-2021-00161
• Device Sequence Number: 3173074
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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: H700124
• Device Catalogue Number: H700124
• Device Lot Number: 5294704
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1