MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY¿ DWS7 V.5.0; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100145077

Device Problem Application Program Problem (2880)

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

Event Date 09/28/2021

Event Type  malfunction  

Event Description

During preparation, after administration of anesthesia, when the pc was powered on, a message stating appeared stating "welcome to emergency mode.Give root password for maintenance" the pc was unable to be used and the error could not be resolved.The procedure was postponed as a result of the issue.The computer was replaced to resolve the issue.There were no adverse patient consequences due to this issue.

Manufacturer Narrative

One ensite velocity¿ display workstation (dws) was received for evaluation.Visual inspection revealed the front panel ports, and labels were free of physical damage.Internal visual inspection revealed all connectors were seated securely and routed correctly.The dws device accessories were connected along with power.Power was applied and the dws passed the power-on-self-test.The dws then displayed a message stating that there is no boot device available which would duplicate the missing hard disk drive.Hardware memory diagnostic testing was successful.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 investigation and information provided to abbott, the reported event was not confirmed, and the root cause remains undetermined.

• Brand Name: ENSITE VELOCITY¿ DWS7 V.5.0
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12655947
• MDR Text Key: 277119070
• Report Number: 2184149-2021-00305
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100145077
• Device Lot Number: 5616773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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