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

Model Number	H700977
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the radio frequency ablation procedure, unexpected shut off issues occurred.The power cycle was retried but with no resolution, the software was not booting up and the case was abandoned.
Additional Manufacturer Narrative
Additional information: g3, h2, h3.The results of the investigation are inconclusive since the device was not returned for analysis.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.No capa is required; the root cause of the reported issue could not be confirmed to be a manufacturing, design, or quality system related occurrence.The reported issue will continue to be monitored for trends and reviewed in qdr (quality data review).Based on the information received, the cause of the reported unexpected shutdown and subsequent cancellation remain unknown.
Event or Problem Description
Device received for evaluation.Follow up report needed to address analysis.
Additional Manufacturer Narrative
Additional information: h6 one claris display workstation (dws) z440 was received for evaluation.Based on the investigation and information provided to abbott, the reported event was not able to be confirmed, however the root cause was attributed to motherboard.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: WORKMATE¿ CLARIS¿ COMPUTER
• Common Device Name: 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: 17662969
• Report Number: 2184149-2023-00172
• Device Sequence Number: 7088146
• 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): 12/19/2023

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 Lot Number: 7894195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/13/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 12/11/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/14/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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