MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE CLARIS SYSTEM AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700169
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer ref: 2184149-2020-00222.During an atrial fibrillation ablation procedure, there was an amplifier error that stated "packet rate out of bounds" and the procedure was cancelled.The error was cleared and the rate detection algorithm was turned off, but the issue remained.The amplifier was exchanged, but the same issue happened with the second amplifier.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One workmate claris amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels had no physical damage.All of the mounting hardware was secured.The returned workmate claris amplifier was powered on and amplifier error message was displayed when connected to a test standard workmate claris computer.Non-signal was displayed using the catheter interface module and ecg simulator.The ecg bio switching card was temporarily replaced with a test standard card and a normal signal display was observed.Using the test standard bio switching card, basic signal acquisition/quality test which included the surface ecg, baseline, amplitude, and stimulus switching were performed and confirmed that all the signals were within the specifications.The communication test was run and no interrupted or drop in communication was observed.However, when the returned ecg bio switching card was reinstalled, the missing signals were displayed.The reported field event was isolated to an intermittent ecg bio switching card.The reported complaint of packet error was confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.The reported field event was isolated to an intermittent ecg bio switching card.

• Brand Name: WORKMATE CLARIS SYSTEM AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10983145
• Report Number: 2184149-2020-00221
• Device Sequence Number: 14208049
• Product Code: DQK
• UDI-Device Identifier: 05415067001696
• UDI-Public: 05415067001696
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H700169
• Device Catalogue Number: H700169
• Device Lot Number: 6874548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WORKMATE CLARIS SYSTEM AMPLIFIER; WORKMATE CLARIS SYSTEM AMPLIFIER
• Outcome Attributed to Adverse Event: Other