MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WM CLARIS CPU; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700977

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

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

Event Date 09/08/2022

Event Type  malfunction  

Event Description

During device preparation with the patient in the room, a communication issue occurred and the procedure was cancelled.The computer turned off unexpectedly and could not be turned back on.The system was attempted to restarted, the power cable was changed and the power source was changed which did not resolve the issue and the case was cancelled.

Manufacturer Narrative

One claris display workstation was received for evaluation.Power was applied to the dws, and the dws passed power-on-self-test (post).The dws loaded the operating system then the workmate claris application successfully.Evaluation of the logs identified that there was soft data corruption.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 confirmed, however the root cause was not able to be isolated and the device worked as per designed.

• Brand Name: WM CLARIS CPU
• 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: 15581605
• MDR Text Key: 305605455
• Report Number: 2184149-2022-00227
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 5336605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• 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