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

Model Number	H700169
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
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
During the procedure, there were no egm or ecg signals displayed on the system and the error message "disconnect amp, 0 data packet" was displayed.The procedure ended up being cancelled.
Event or Problem Description
During the procedure, there were no egm or ecg signals displayed on the system and the error message "disconnect amp, 0 data packet" was displayed.The procedure ended up being cancelled and 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 successful communication was established with the test standard workmate claris computer.A basic signal acquisition/quality test which included the surface ecg, baseline, amplitude and stimulus switching were performed using a test media converter and confirmed that the returned amplifier performed within the factory specifications.The communication test was run for over 24 hours and no loss or drop in communication was observed.No noise artifact, ecg signal issue or packet error was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The reported complaint of noise artifacts could not be confirmed as the workmate claris amplifier functioned as intended.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM AMPLIFIER
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9177015
• Report Number: 2184149-2019-00186
• Device Sequence Number: 2830591
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• 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,Followup
• Report Date (Section B): 10/29/2019

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 Lot Number: 5310972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/13/2019; 10/24/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/14/2019; 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other