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

Model Number	H403023
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, the message "ep-4 hardware is not responding" was displayed and because of such, pacing could not be applied as planed and the procedure was only completed to the minimum standard.Multiple troubleshooting steps were attempted to resolve the issue, but the issue remained.The procedure was still able to be completed with an emergency stimulation box with no adverse consequences to the patient, but without pacing or post pacing as planned.During further troubleshooting, the media converter was exchanged and the issue was resolved.
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 incident could not be determined.

• Brand Name: WORKMATE CLARIS SYSTEM MEDIA CONVERTER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11324312
• Report Number: 2184149-2021-00045
• Device Sequence Number: 19902215
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K092913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: No Information
• Device Model Number: H403023
• Device Catalogue Number: H403023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1