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

Model Number	H700123
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure with the patient on the table, the system was turned on without success.The system was rebooted which did not resolve the issue.The procedure was cancelled and will be rescheduled.There were no consequences to the patient.
Additional Manufacturer Narrative
Based on the information provided to abbott and the investigation performed, changes made to the system ini (initialization) configuration settings prevented a normal boot sequence or initialization.The configuration settings within the initialization file were corrected to resolve the issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.It is unknown how or when the configuration settings were changed.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM
• 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: 7771613
• Report Number: 2184149-2018-00121
• Device Sequence Number: 1392109
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132073
• 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): 10/03/2018

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 Lot Number: 6201611
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other