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

Model Number	H700124
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
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, there were no signals visible on the system and the case was abandoned.There were no consequences to the patient.
Additional Manufacturer Narrative
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.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported signal issue and subsequent cancellation remains unknown.

• Brand Name: WORKMATE CLARIS SYSTEM DISPLAY PLUS
• 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: 10678785
• Report Number: 2184149-2020-00175
• Device Sequence Number: 16920402
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 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: Other
• Device Model Number: H700124
• Device Catalogue Number: H700124
• Device Lot Number: 6677760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 01/22/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 10/15/2020; 01/07/2021
• 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