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

Model Number H700123

Device Problems Display or Visual Feedback Problem (1184); Application Program Version or Upgrade Problem (2881)

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

Event Date 04/06/2021

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

Following a software upgrade to v1.2, when using interval calipers, there were 2 sets of calipers opened.When the right leg was locked down, the second set of calipers disappeared.There is no further information available.

Manufacturer Narrative

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

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM
• 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: 11851805
• MDR Text Key: 252083307
• Report Number: 2184149-2021-00175
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• 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: H700123
• Device Catalogue Number: H700123
• Device Lot Number: 7634027
• Was Device Available for Evaluation?: No
• 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: 09/02/2020
• 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