MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY DWS7 V.5.0.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	100149280
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
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
Prior to the procedure, following patient preparation, the case was cancelled due to a computer startup issue.When booting the pc, the pc would beep and flash red but never fully start up.The procedure was cancelled and there were no adverse patient consequences.
Additional Manufacturer Narrative
One ensite velocity¿ dws7 was received.Ac power was successfully applied to the velocity dws and the display workstation failed to successfully execute the hardware self-test.The power on button flashed red five times while simultaneously emitting five audible tones.This is an indication of a ram (random access memory) fault which was resolved by removing the second processor module.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.Based on the information provided to abbott and the investigation performed, the root cause of the reported event has been isolated to abnormal functionality of the second processor module assembly and subsequent memory module fault.

• Brand Name: ENSITE VELOCITY DWS7 V.5.0.1
• 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: 9765843
• Report Number: 2184149-2020-00029
• Device Sequence Number: 2456723
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: Health Professional
• Device Model Number: 100149280
• Device Catalogue Number: EE3000
• Device Lot Number: 6376989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/06/2020
• 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