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

Model Number H700977

Device Problem Failure to Power Up (1476)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported power issue and subsequent cancellation remain unknown.

Event Description

During the procedure with the patient prepped, the workmate claris display workstation continuously booted up and the case was abandoned.

Manufacturer Narrative

Additional information: d9, g1, g3, h2, h3, h6 one claris computer sn (b)(6) was returned for investigation.Visual inspection revealed the unit was damaged being repair and multiple boards and pieces were falling off.Due to the state of the return, no functional testing was possible.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: WORKMATE¿ CLARIS¿ COMPUTER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17737147
• MDR Text Key: 323317716
• Report Number: 2184149-2023-00174
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700977
• Device Lot Number: 6012319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1