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

Model Number	H701806
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Visible smoke was noted on the printer for the claris system.There was no patient involved.
Additional Manufacturer Narrative
Additional information: d3, d4, d9, g3, h2, h3, h4, h6.One hewlett packard color laser jet pro was received for evaluation.Evaluation testing required using a power, universal serial bus (usb) cable, and a claris display workstation.Testing revealed that upon first power-up, the printer started its power-on-self-test (post), which was successful.When completed, it stated it was lacking paper.Paper was added and test page, network page, and a cleaning page was attempted.Power input and input module testing was performed and noted to be good.The side panel was then removed to help identify the location of the smoke.During this time no smoke was visible, but a smell did begin, then smoke was seen from the power module board area prior to the motors.The power assembly was de-installed and inspected and thermal damage was noted to the main capacitor (c125), which is where the smoke was originating.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 investigation and information provided to abbott, the reported event was attributed to the power supply board within the printer.

• Brand Name: WORKMATE¿ CLARIS¿ PRINTER
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20545331
• Report Number: 2184149-2024-00180
• Device Sequence Number: 17948315
• Product Code: DQK
• UDI-Device Identifier: 05415067018069
• UDI-Public: (01)05415067018069(10)10307479
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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 Model Number: H701806
• Device Catalogue Number: H701806
• Device Lot Number: 10307479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown