MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM 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	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrioventricular nodal reentrant procedure, a communication issue occurred which caused a delay.As the system was started, all the connections were operational.Ten minutes into the procedure, the amplifier disconnected.All systems were rebooted which did not resolve the issue.The fiber optic cable between the amplifier and dws was changed as well as the media converter, however the issue remained.The amplifier connection was checked for error messages, but there were none.The system was turned off and on again and it started working.After 1 hour of waiting, the amplifier had not disconnected and the procedure continued.
Additional Manufacturer Narrative
Additional information: g3, h2, h3 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.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported communication issue and subsequent delay remains unknown.
Additional Manufacturer Narrative
One claris¿ amplifier 56 channel was received for evaluation.Power was applied to the amplifier and 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 signals were not displayed.Internal visual inspection revealed that the signal loss was due to an internal cable that was dis-connected from the bioswitch card to the pressure card.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to an intermittent single board computer.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM 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: 15586397
• Report Number: 2184149-2022-00229
• Device Sequence Number: 19523399
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: 05415067001696
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K210392
• 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): 07/12/2024

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: 5899051
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 06/20/2024
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 12/08/2022; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2017
• 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 Sex: Unknown