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 Power Up (1476)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
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 a power outage, the cpu would not boot back into the program.Despite several power cycling attempts.The procedure was allegedly cancelled.
Event or Problem Description
During a power outage, the cpu would not boot back into the program, despite several power cycling attempts.The procedure was beyond the therapy stage so no additional recording or ablation was done after this event.The case was ended and the patient was discharged in stable condition.The patient needed to be rescheduled for a second part of the procedure which was not attempted after the system went down.The system was rebooted and eventually came back online.A ups was installed to resolve the issue.
Additional Manufacturer Narrative
Additional information: b5, g4, g7, h2, h3, h6.A review of the device history record was not possible since the system serial number was provided and the component serial number was not.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 conclusively determined.

• 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: 9382901
• Report Number: 2184149-2019-00237
• Device Sequence Number: 18952490
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: H700124
• Device Catalogue Number: H700124
• Device Lot Number: 6044048
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1