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

Device Problem Smoking (1585)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

During install, the printer began smoking after being plugged into the power outlet.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One workmate¿ claris¿ system color printer was received for analysis.Visual inspection of the returned color printer indicated no physical damage was detected on the chassis input and output ports or exterior chassis.All ink cartridges were properly installed and contain adequate levels for use.Ac power was applied to the returned product which emitted a burning odor, which confirmed the reported issue.Inspection of the internal components revealed a buildup of ink toner at the main fuser assembly.Functional testing confirmed acceptable print quality and functionality in both color and greyscale modes of operation.Review of the device history record was not possible as the lot number is unknown.Based on the information provided to abbott and the investigation performed, the reported event was isolated to a buildup of ink toner within the device.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM PRINTER
• 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: 12907808
• MDR Text Key: 281502634
• Report Number: 2184149-2021-00378
• Device Sequence Number: 1
• Product Code: DQK
• 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
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1