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

Model Number H700977

Device Problems Application Program Problem (2880); Application Program Version or Upgrade Problem (2881)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation revealed that after the workmate claris v.1.2 software upgrade, the workmate claris dws screen turns black/blank and the user needs to reboot the system to regain functionality.

Event Description

During the procedure, the user halted pacing.The user then attempted to take measurement on the review screen.The mouse-point disappeared on the screen and both screens went black.The computer was re-booted and the issue was resolved.The study was then able to be completed.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional data: g3, h2, h10 corrected data: h6.

• Brand Name: WM CLARIS CPU
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11851769
• MDR Text Key: 252083418
• Report Number: 2184149-2021-00174
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 5483048
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2184149-05/05/21-001-R
• Patient Sequence Number: 1