MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SWAP EP-WORKMATE COMPUTER; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number	H700096
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During preparation for an atrial fibrillation ablation procedure a cancellation occurred due to a software lockup.Following iv placement the pc would freeze and shutdown.The issue was not resolved and the procedure was rescheduled.There were no adverse patient consequences.
Additional Manufacturer Narrative
One ep-workmate computer was received for evaluation.The computer was powered on, however, the computer booted to an error screen requesting to start normally or to repair windows.An attempt was made to restart normally to no avail.Computer system hardware diagnostic testing was performed and no anomaly was observed.System repair testing was performed and the computer booted normally.Review of system events log indicated that the system had loss power unexpectedly around to the date of the reported event.This action may prompt the operating system error recovery and a hardware resynchronization process.This issue may also impact the system performance due to an excessive system disk input/output transfer rate during the hardware resynchronization.The root cause of the reported event was isolated to an improper shut down or unexpected loss of power which may impact the overall system performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.

• Brand Name: SWAP EP-WORKMATE 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: 7637512
• Report Number: 2184149-2018-00096
• Device Sequence Number: 1788480
• Product Code: DQK
• UDI-Device Identifier: 05415067000965
• UDI-Public: 05415067000965
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K132073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H700096
• Device Lot Number: 5690774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 06/26/2018
• 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
• Outcome Attributed to Adverse Event: Other