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

Model Number H700332

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Prior to a procedure with the patient prepped for the case, a startup issue occurred and the case was cancelled.The screen that displays the study menu did not load and the procedure was cancelled to install a back up.There were no consequences to the patient.

Manufacturer Narrative

One workmate¿ claris¿ system computer was received for evaluation.As received, the computer was powered on, however, the computer booted to the following error message-"921-front usb not connected".The computer was power cycled several times to no avail.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.Further analysis revealed that 921 usb connector cable was disconnected from the chassis.

• Brand Name: DWS FOR WORKMATE CLARIS SYSTEM
• 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: 9304170
• MDR Text Key: 166368129
• Report Number: 2184149-2019-00221
• Device Sequence Number: 1
• Product Code: DQK
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700332
• Device Lot Number: 5217460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other