MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY DWS7 DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100129557

Device Problem Operating System Version or Upgrade Problem (2997)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a left sided atrial flutter ablation procedure, some of the catheters were not available on the computer and the procedure was cancelled.The liveview was previously installed on the system, however the catheter catalog could not be installed.The procedure was cancelled and there were no adverse consequences to the patient.

Manufacturer Narrative

One ensite velocity¿ dws7 computer was received for evaluation.Visual inspection of the returned computer verified the connectors and labels were free of physical damage.The computer successfully booted to the menu application upon applying ac power.It was observed the software license entitlement was issued to hostname dwsg703892 which matches the applied chassis label.The field reported event was confirmed as the intended catheter was not located in the catheter catalog.Review of installment logs confirmed an incomplete installation as error message ¿error > db prepare statement failed¿ were observed.Further inspection verified the computer was left-on for an extended period with no anomaly observed and a successful hard disk drive and memory diagnostic test was performed.The root cause was isolated to the soft-data upgraded on the hard disk drive from an incomplete installation due to user error.A review of receiving inspection results for this serial number confirmed that no non-conformances were identified related to the reported event and the product met abbott specifications.The field reported event was confirmed.Based on the information provided to abbott and the investigation performed, the root cause was isolated to the soft-data upgraded on the hard disk drive from an incomplete installation cause by user error.

Manufacturer Narrative

One ensite velocity¿ dws7 computer was received for evaluation.Visual inspection of the returned computer verified the connectors and labels were free of physical damage.The computer successfully booted to the menu application upon applying ac power.It was observed the software license entitlement was issued to hostname dwsg703892 which matches the applied chassis label.The field reported event was confirmed as the intended catheter was not located in the catheter catalog.Review of installation logs confirmed an incomplete installation as error message ¿error > db prepare statement failed¿ were observed.Further inspection verified the computer was left-on for an extended period with no anomaly observed and a successful hard disk drive and memory diagnostic test was performed.The root cause was isolated to an incomplete upgrade performed.A review of receiving inspection results for this serial number confirmed that no non-conformances were identified related to the reported event and the product met abbott specifications.Based on the information provided to abbott and the investigation performed, the root cause was isolated to an incomplete upgrade performed.

• Brand Name: ENSITE VELOCITY DWS7 DISPLAY WORKSTATION
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11031729
• MDR Text Key: 222308293
• Report Number: 2184149-2020-00238
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K172396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

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
• Device Operator: Health Professional
• Device Model Number: 100129557
• Device Lot Number: 6657369
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/28/2021; 03/29/2021
• Supplement Dates FDA Received: 01/28/2021; 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR