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	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an ep/v stim study procedure, a communication issue occurred and the procedure was cancelled.There were no signals and a ¿check connections¿ error message was noted.Re-booting multiple times did not resolve the issue.The fiber optic cable, media converter, and ethernet cable were replaced with no resolution and the amplifier was suspected as the issue.The issue was identified while the patient was on the table being set up and multiple attempts were made to correct the connection issue without success.The physician did place one catheter to attempt stimming maneuver but ultimately decided to abort the procedure.
Additional Manufacturer Narrative
Additional information: a2, a3a, a4, a5, d9, e1, g3, h2, h3, h6.One workmate¿ claris¿ amplifier was received for evaluation.Visual inspection revealed the connectors, chassis, and label were free of physical damage.When power was applied, the amplifier passed post (power-on-self-test) and communication was established.Electro-cardiogram (ecg) and intra-cardiac (ic) signals were observed.The amplifier was power cycled multiple times during investigation which no anomalies observed.The amplifier was left on for an extended period with no disruption to communication.The reported symptom was not duplicated as the amplifier was able to communicate every time it was connected.Inspection of the log files identified a ¿bio card(0) command timeout¿ error message.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 reported symptom was not duplicated during investigation, however the root cause was isolated to an intermittent bio-switch board in slot 0.

• 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: 22792643
• Report Number: 2184149-2025-00141
• Device Sequence Number: 8286919
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: (01)05415067001696(10)5929460
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: H700169
• Device Catalogue Number: H700169
• Device Lot Number: 5929460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2017
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 163 KG
• Patient Ethnicity: Non Hispanic