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

Model Number H700977

Device Problem Failure to Power Up (1476)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

During the procedure, the system would not boot up and the display would not appear on the monitors and the procedure was cancelled.There were no adverse consequences to the patient.

Manufacturer Narrative

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 determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformance's associated with the reported event were identified.

Manufacturer Narrative

One claris display workstation (dws) z440 was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels were free of physical damage.Power was applied to the dws, and the dws did not achieve the splash screen, which duplicates the reported symptom.The motherboard did not begin the power-on-self-test (post), and thus never tried the solid state hard drives.Based on individual part removal the root cause was attributed to the mother board.Based on the investigation and information provided to abbott, the reported event was confirmed, and the root cause was attributed to the mother board.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.

• Brand Name: WM CLARIS CPU
• 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: 12967353
• MDR Text Key: 281982534
• Report Number: 2184149-2021-00401
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: 6796051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• 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