MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY HDD VELOCITY V.4.0.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H701333

Device Problem Output Problem (3005)

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

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.

Event Description

Prior to the procedure, after the patient was prepped, the computer was started and proceeded through the booting setups.An error appeared on the screen, which read ¿failed to start the x server".The computer was restarted three times but the same error would appear.The procedure was cancelled and there were no consequences.

Manufacturer Narrative

Additional information: g4, g7, h2, h3, h6, h10.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Manufacturer Narrative

One ensite velocity¿ dws6 computer was received for evaluation.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 a non-functional hard disk drive and a non-functional system motherboard.

• Brand Name: ENSITE VELOCITY HDD VELOCITY V.4.0.1
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9406771
• MDR Text Key: 169013227
• Report Number: 2184149-2019-00243
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H701333
• Device Catalogue Number: H701333
• Device Lot Number: 4831280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 75