MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM COMPUTER Z620; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700977

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an ablation procedure the computer was running as intended, but then displayed an error message about system recovery options.Troubleshooting was performed by clicking on startup repair, system restore and windows memory diagnostic option but the issue remained.The procedure was unable to be completed.There were no adverse consequences to the patient.

Manufacturer Narrative

One workmate¿ claris¿ system computer z620 was received for evaluation.Visual inspection revealed the input/output connectors had no physical damage.The computer was powered on, however, the computer booted to an error screen requesting to start normally or to repair windows.The computer was started normally and the message: "windows has recovered from an expected shutdown" was displayed.Review of system events log indicated that the system had loss power unexpectedly in and around to the date of the reported event.This action may prompt the operating system error recovery and a hardware resynchronization process.This issue may also impact the system performance due to an excessive system disk input/output transfer rate during the hardware re-synchronization.Computer system hardware diagnostic testing was performed, and no anomaly was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the reported event was confirmed.The root cause of the reported event was isolated to an improper shut down or unexpected loss of power which may impact the overall system performance.Upon power up, the computer recovered from the unexpected shutdown and computer system hardware diagnostic testing was performed and no anomaly was observed.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM COMPUTER Z620
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9186060
• MDR Text Key: 162503474
• Report Number: 2184149-2019-00184
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K132073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 5582452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other