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

Model Number 100083711

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During a procedure, after the patient was prepared for surgery, the claris system froze.The issue could not be resolved and the procedure was cancelled.There were no adverse patient consequences.

Manufacturer Narrative

The product was not returned for analysis; however event details indicate issue was resolved on-site by allowing the device to be powered on for an extended period of time so the file system could be repaired.Based on the information received, the cause of the reported system freeze and subsequent cancelled prcedure could not be conclusively determined.If the issue persists it is recommended to return the product for evaluation; however for the time being the system is still in use with the customer.

• 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: 9640165
• MDR Text Key: 176758154
• Report Number: 2184149-2020-00013
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100083711
• Device Catalogue Number: 100083711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other