MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, the amplifier sporadically disconnected from the system and the procedure was canceled.The system was power cycled which did not resolve the issue and the case was cancelled with no consequences to the patient.
Additional Manufacturer Narrative
One claris¿ amplifier was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels were free of physical damage.Power was applied to the amplifier and the amplifier passed power-on-self-test (post).The amplifier went status ready and communicated with the test claris computer.The electro-cardiogram (ecg) and intra-cardiac (ic) signals were imported with an ecg stimulator to each channel and all the ecg and ic channels were observed and without observable electrical noise.The amplifier logs were pulled and inspected, and no anomalous logs were observed for the reported event date.The amplifier was then connected back into the display workstation active study and left on while observing the communications line for an extended amount of time.The logs for the day show no communication symptoms throughout the study session, however the system logs did show a bio board sequence symptom, which was due to the remote access (time match) when checking the logs.Based on the investigation and information provided to abbott, the reported event was not able to be confirmed as evaluation testing was successful.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.The cause of the reported communication issue remains unknown.

• Brand Name: WORKMATE¿ CLARIS¿ AMPLIFIER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17436366
• Report Number: 2184149-2023-00154
• Device Sequence Number: 6779960
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: 05415067001696
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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 Lot Number: 6360800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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