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

Model Number Velocity¿

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  Injury  

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 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.

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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9521611
• MDR Text Key: 173300344
• Report Number: 2184149-2019-00255
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067000910
• UDI-Public: 05415067000910
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: Velocity¿
• Device Catalogue Number: EE3000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2020
• Patient Sequence Number: 1