MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE CLARIS DISPLAY PLUS WITHOUT EP-4; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H701703
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined.
Event or Problem Description
During an atrial fibrillation (af) procedure, the baseline was displayed in real time, but an error massage "amplifier errors" was displayed.When "clear errors" was pressed this did not resolve the issue.The amplifier and dws were power cycled with no resolution.The optical cable was exchanged and reboot was done.An error message "amplifier errors" was still displayed.However, when "clear errors" was pressed, "amplifier connected" was displayed.The procedure continued, and suddenly, an error massage "amplifier disconnected" was displayed, and no waveform was displayed on the real-time screen.The connection of the optical cable was checked, but there was no problem, and "clear errors" was grayed out and could not be pressed.When "restart" was pressed and a reboot was attempted, the problem did not change at first, but after 4-5 reboots, communication was established.The procedure was completed without replacing the system and there were no adverse consequences to the patient.A delay occurred due to these issues.

• Brand Name: WORKMATE CLARIS DISPLAY PLUS WITHOUT EP-4
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11919390
• Report Number: 2184149-2021-00153
• Device Sequence Number: 804934
• Product Code: DQK
• UDI-Device Identifier: 05415067017031
• UDI-Public: 05415067017031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/02/2021

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: H701703
• Device Catalogue Number: H701703
• Device Lot Number: 5143552
• 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: 05/11/2021
• Initial Report FDA Received Date: 06/02/2021
• Patient Sequence Number: 1