MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC ENSITE¿ VELOCITY¿ HP Z620 DWS6 COMPUTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H701333

Device Problem Application Program Problem (2880)

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

Event Date 09/08/2022

Event Type  malfunction  

Event Description

During a 3d mapping and catheter ablation procedure of a right sided premature atrial contraction (pac), the screen froze causing a delay.After creating the 3d map and before starting the ablation catheter, the ensite screen froze.The mouse cursor did not move and when a command was applied with the keyboard, the system did not do anything.The system was manually restarted and forcefully, after waiting 20 minutes for the system to respond, the option "last study" was selected to recover the map but it was lost.It was necessary to restart the complete study, which delayed the procedure by one hour.The procedure was completed with no adverse effect or consequences to the patient.

Manufacturer Narrative

Additional information: g3.H2, h3.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 crash and subsequent delay could not be determined.It should be noted that after freeing up some disk space, the device functioned as intended.

• Brand Name: ENSITE¿ VELOCITY¿ HP Z620 DWS6 COMPUTER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15509208
• MDR Text Key: 301119036
• Report Number: 2184149-2022-00240
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

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
• Device Operator: Health Professional
• Device Model Number: H701333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 63 KG