MAUDE Adverse Event Report: ABBOTT MEDICAL 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	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a pfa pvi procedure, a communication issue occurred and the procedure was cancelled.There were no signals on the workmate claris system, and an error message was noted stating: "check connections".The connections were checked and the system was rebooted which did not resolve the issue and the procedure was cancelled.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6 one workmate¿ claris¿ amplifier 56 channels was received for evaluation.Visual inspection revealed no sign of physical damage on the connectors, chassis, and label.When power was applied, the amplifier did not make the last beep indicating an unsuccessful post (power-on-self-test).The amplifier was opened, and internal visual inspection revealed all mounting hardware were secured.The sbc (single board computer) was temporarily replaced with a known-good one which post was completed successfully.Electro-cardiogram (ecg) and intra-cardiac (ic) signals were imported with an ecg stimulator to each channel and the ecg and ic signals were observed.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.Based on the information and investigation provided to abbott, the root cause was isolated to the sbc.

• Brand Name: WORKMATE¿ CLARIS¿ AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22345394
• Report Number: 2184149-2025-00125
• Device Sequence Number: 14677747
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: (01)05415067001696(10)7297042
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: H700169
• Device Catalogue Number: H700169
• Device Lot Number: 7297042
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• 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