MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY CARDIAC MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	EE3000
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional 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.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined. .
Event or Problem Description
During an av-nodal reentrant tachycardia (avnrt) procedure, after video returned to the remote monitor, while a few minutes into the case, the computer froze.It was noted that only basic data entry was being performed at the time and no mapping was being performed.The system was plugged into a normal ac outlet.A hard reboot of the dws was done.Upon reboot, no errors appeared, however, the pc froze for a second time and another reboot was performed.Once rebooted, the pc was able to function but was slow/lagging.The procedure was able to be completed with no adverse patient consequences.A delay occurred due to these issues.

• Brand Name: ENSITE VELOCITY CARDIAC MAPPING SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12120636
• Report Number: 2184149-2021-00207
• Device Sequence Number: 17334408
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EE3000
• Device Catalogue Number: EE3000
• Device Lot Number: 7835643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1