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

Model Number	H700977
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined.
Event or Problem Description
Manufacturer report numbers: 2184149-2021-00286, 2184149-2021-00288.During the procedure, after booting on the system, pacing was performed and successful measurement and patient diagnosis was done.After pressing the ablation button, a hardware malfunction message appeared on the system monitoring screen: "nmi: parity check / memory parity error.The system has halted" and the system could not operate as intended.The dws and the cpu were restarted, but the issue persisted.After overall patient condition assessment, it was decided to stop the procedure.There were no adverse patient consequences to the patient due to these issues.Product replacement is not possible for this customer, so no equipment will be returning for investigation.

• 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
• MDR Report Key: 12490826
• Report Number: 2184149-2021-00287
• Device Sequence Number: 20173337
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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: 5607961
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1