MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE CLARIS SYSTEM V.1 ADDITIONAL MONITOR MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700178

Device Problem Smoking (1585)

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

Event Date 01/19/2021

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.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined.

Event Description

During device preparation, the split screen started to smoke.After replacing the splitter and the screen, the issue was resolved.There were no adverse consequences to the patient or user.

• Brand Name: WORKMATE CLARIS SYSTEM V.1 ADDITIONAL MONITOR MODULE
• 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: 11320997
• MDR Text Key: 231580333
• Report Number: 2184149-2021-00015
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001733
• UDI-Public: (01)05415067001733(10)
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2017
• 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