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

Model Number	H700123
Medical Device Problem Codes	Failure to Power Up (1476); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During the procedure, the system had did not start.The amplifier and connections were checked, but the issue remained.The procedure was cancelled.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, the cause of the reported incident could not be determined.
Additional Manufacturer Narrative
One workmate claris amplifier with pn 100084422 and sn 15870458 was received for evaluation.The returned workmate claris amplifier was powered on but no communication was established with the test standard workmate claris computer.The single-board computer (sbc) was temporarily replaced with a known good sbc board and successful communication was established with the test standard workmate claris computer.Using the test standard sbc board, the amplifier was run for a few hours, and no interruption or loss of communication was observed.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.

• Brand Name: WORKMATE CLARIS SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11143175
• Report Number: 2184149-2021-00006
• Device Sequence Number: 4050651
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2021

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: H700123
• Device Catalogue Number: H700123
• Device Lot Number: 5350321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 02/01/2021; 03/29/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/03/2021; 03/31/2021
• 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