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

Model Number H700123

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

Event Type  Injury  

Event 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.

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
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 7771613
• MDR Text Key: 116702214
• Report Number: 2184149-2018-00121
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• Combination Product (y/n): N
• PMA/PMN Number: K132073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/03/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other