MAUDE Adverse Event Report: ENSITE VELOCITY¿ VELOCITY DWS5.1 CHASSIS; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100052392

Device Problems Failure to Power Up (1476); Application Program Problem (2880); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  malfunction  

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.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported incident could not be determined.

Event Description

During the procedure, the computer turned off while attempting to map and would not turn back on, which resulted in the procedure having to be cancelled.Initially the connections were checked, but the issue remained.The computer displayed an error message when checking the system files and then the computer would not start.There were no adverse consequences to the patient.

• Brand Name: ENSITE VELOCITY¿ VELOCITY DWS5.1 CHASSIS
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• MDR Report Key: 12646665
• MDR Text Key: 276847707
• Report Number: 2184149-2021-00315
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100052392
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1