MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. DAKO COVERSTAINER; AUTOMATED SLIDE STAINER

Model Number	CS100
Medical Device Problem Codes	Mechanical Problem (1384); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The brazil customer reported that the dako coverstainer lower door's shock absorbers, which are used to support the door, occasionally descended when it was opened.The agilent representative reported that the shock absorbers were not replaced during the previous preventive maintenance as they were out of stock locally at the time of service.Upon receipt of the shock absorbers in inventory, the field service engineer (fse) performed the service and replaced the shock absorbers on the instrument.The instrument has been repaired; it is fully operational and is available to the user.This issue does not affect the utility of the instrument, and the customer was able to complete staining.User harm was not indicated or reported.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: DAKO COVERSTAINER
• 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: 23617647
• Report Number: 3003423869-2025-00049
• Device Sequence Number: 18653258
• Product Code: KPA
• UDI-Device Identifier: 05700571112571
• UDI-Public: (01)05700571112571(11)220401
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: CS100
• Device Catalogue Number: CS10030
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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