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

Model Number H700977

Device Problems Failure to Power Up (1476); Application Program Version or Upgrade Problem (2881)

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

Event Date 03/31/2021

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 service, there was a computer boot failure following a config change.The computer booted to blank screen.There was no patient involved.

Manufacturer Narrative

Additional data: g3, h2, h10.

• Brand Name: WM CLARIS CPU
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 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: 11854553
• MDR Text Key: 251662523
• Report Number: 2184149-2021-00179
• 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: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 7852943
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Date Device Manufactured: 02/26/2021
• 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