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	Device Remains Activated (1525); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the first slide position of the instrument was hot to the touch while the instrument was not in use.It was confirmed that only the first slide position was affected by the issue.An agilent field service engineer (fse) went on site to service the instrument but was unable to verify the customer's reported issue, as upon inspection the heater remained cold and unable to operate.It was found that the heater cables had shorted causing the thermal fuse to be triggered resulting in the heater being disabled.The fse replaced all required components.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 reoccur.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; SG 768923
• Manufacturer Contact: benjamin gaither ; 1834 state highway 71 west; cedar creek, TX 78612
• MDR Report Key: 23488557
• Report Number: 3003423869-2025-00048
• Device Sequence Number: 10558589
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: (01)05700571108451(11)250126
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2025
• 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