MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. ARTISAN LINK PRO SPECIAL STAINING SYSTEM; AUTOMATED SLIDE STAINER

Model Number	AR310
Medical Device Problem Codes	Leak/Splash (1354); Device Remains Activated (1525); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While on-site addressing an aspiration-related issue, the agilent field service engineer (fse) found that the heaters for slide positions 2-5 and 12-16 were consistently staying on when the artisan instrument was idle.These heaters were remaining active as heater control boards 1 and 2 had been damaged by a defective vacuum pump which was incorrectly aspirating.The fse serviced the instrument by replacing the heater control boards and all required components.After repair, the instrument is fully operational and ready for use.While there was no direct, or indirect, user harm reported for this event; it is being reported due to the potential for harm if the event were to recur.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.

• Brand Name: ARTISAN LINK PRO SPECIAL STAINING SYSTEM
• Common Device Name: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: benjamin gaither ; 1834 state highway 71 west; cedar creek, TX 78612 ; 5123328207
• MDR Report Key: 23330813
• Report Number: 3003423869-2025-00045
• Device Sequence Number: 21309594
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: 05700571108451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: AR310
• Device Catalogue Number: AR31030
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2016
• 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