MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE AND WORKMATE CLARIS EP-4 TOUCHSCREEN COMPUTER; GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE

Model Number	H21911
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
The touch screen interface was smoking from the back top right of the monitor prior to the procedure.The system had been on for about 15-20 minutes and all the sudden started smoking.It was unplugged from the power and bypassed directly to the workmate cpu and the case was completed with no further issues.
Additional Manufacturer Narrative
Corrected data: brand name.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformance were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined.The customer will not be shipping the system and want nothing done with it as they have purchased a new one.The touchscreen has been disconnected and unused since the event.

• Brand Name: EP-WORKMATE AND WORKMATE CLARIS EP-4 TOUCHSCREEN COMPUTER
• Common Device Name: GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8582516
• Report Number: 2184149-2019-00084
• Device Sequence Number: 16771960
• Product Code: JOQ
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2019

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: H21911
• Device Catalogue Number: H21911
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 05/07/2019; 05/07/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/10/2019; 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other