MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number	H21911
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to the procedure, when the touchscreen computer was powered on smoke was noted to be coming from the device.There were no adverse consequences to the staff and no patient was involved.
Additional Manufacturer Narrative
One ep-workmate¿ and workmate¿ claris¿ ep-4¿ touchscreen computer was received into the lab for analysis.Visual inspection of the returned touchscreen pc indicated all i/o connectors and labels were free of physical damage.It was also verified all external hardware was secured and no physical damage was observed on the display panel or the exterior casing.Inspection of the internal components revealed a melted power cable connector at the hard disk drive due to excessive heat.No additional functional testing was performed as the returned device was received in a condition that does not permit a complete evaluation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated to abnormal functionality of the hard disk drive and subsequent melting of the power cable.

• Brand Name: EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER
• Common Device Name: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 7697921
• Report Number: 2184149-2018-00108
• Device Sequence Number: 904810
• Product Code: DQK
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: H21911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1