MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number	H21911
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation, smoke emitted from the back of the touchscreen.There was no patient involved, therefore there were no adverse patient consequences.
Additional Manufacturer Narrative
The results of the investigation confirmed electrical overstress (eos) damage on the hard disk drive power connector.The smoke observed in the field was consistent with the electrical overstress damage observed on the hard disk drive power connector.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER
• 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: 7637483
• Report Number: 2184149-2018-00091
• Device Sequence Number: 19461085
• Product Code: DQK
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 08/21/2018

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
• Device Lot Number: 6504202
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1