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

Model Number	H700977
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2184149-2021-00401
• Device Sequence Number: 4416447
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 01/05/2022; 02/16/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/05/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown