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	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported that multiple heating elements on the artisan instrument were staying on after a run was completed on (b)(6) 2025.An agilent field service engineer (fse) serviced the instrument and verified the customer's complaint.42 heaters had short circuited due to an aspiration issue which caused reagent to overflow onto a heater control board.The fse replaced the 42 heaters and all required components.The instrument is fully operational and ready for use.Testing was able to be completed with another instrument.Reagent spilling onto the heater control board has the potential to short circuit the heater control board and not provide accurate data flow and signal transmission to the respective heater plates causing them to remain on when unintended.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: angela bandy ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338121
• MDR Report Key: 21967022
• Report Number: 3003423869-2025-00037
• Device Sequence Number: 8350799
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: (01)05700571108451(11)230830
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: 03/13/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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