MAUDE Adverse Event Report: ABBOTT MEDICAL WORKMATE¿ CLARIS¿ AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700150
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an svt procedure after the patient was prepped, it was reported that there was no communication between the workmate claris amplifier and the dws causing a delay.The issue was resolved after restarting the workmate claris system three times.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received by abbott, the cause of the reported incident could not be determined.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 delay of the procedure did not result in a serious injury or death to the patient, and as the customer is still using the amplifier with no continued issues, a device malfunction was not confirmed nor reproducible.Since no malfunction was confirmed, this event no longer meets reporting criteria for a reportable malfunction.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.One claris¿ amplifier 120 channel sn: (b)(6) was received for evaluation.It was noted that during the channel walk test, a packet rate condition appeared.This was isolated to the firmware of the single board computer (sbc).Based on the investigation and information provided to abbott, the reported event was confirmed, and the root cause was attributed to the firmware of the sbc.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.
Event or Problem Description
The device was received for evaluation.This report includes an updated analysis.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22948557
• Report Number: 2184149-2025-00145
• Device Sequence Number: 9636056
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: (01)05415067001504(10)8959787
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 8959787
• Was Device Available for Evaluation?: No
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 11/10/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/08/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown