MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM MEDIA CONVERTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	Velocity¿
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.
Event or Problem Description
During the procedure, the dws computer could not boot to login screen.All the usb devices were disconnected with no resolution.Further troubleshooting revealed the issue was due to the digital converter.The patient was prepped and the procedure was cancelled with no patient consequences.
Additional Manufacturer Narrative
No product was returned for investigation. a review of the device history record was not possible since the batch number is unavailable.Based on the information provided to abbott, the reported boot issue and subsequent cancellation could not be confirmed.

• Brand Name: ENSITE VELOCITY SYSTEM MEDIA CONVERTER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9521611
• Report Number: 2184149-2019-00255
• Device Sequence Number: 458919
• Product Code: DQK
• UDI-Device Identifier: 05415067000910
• UDI-Public: 05415067000910
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: No Information
• Device Model Number: Velocity¿
• Device Catalogue Number: EE3000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1