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	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The spain customer reported " inferior door spring does not work normally" for the cover stainer instrument.The problem was described as the door closes suddenly and the shock absorbers are not working correctly.It was confirmed that no harm has occurred.The agilent field service engineer (fse) went on site to verify functionality before cleaning and lubricating the shock absorbers.Replacement shock absorbers have been ordered and will be installed during the next service visit.Upon confirmation of the replacement, a follow-up report will be submitted.Testing was able to be completed.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.
Additional Manufacturer Narrative
The following fields were updated: b4, b5, g3, g6, h2, h7, h11.
Event or Problem Description
The spain customer reported " inferior door spring does not work normally" for the coverstainer instrument.The problem was described as the door closes suddenly and the shock absorbers are not working correctly.It was confirmed that no harm has occurred.The agilent field service engineer (fse) went back to the customer's site and replaced the shock absorbers.The instrument is fully operational and ready for use.Testing was able to be completed.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: angela bandy ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338121
• MDR Report Key: 21528515
• Report Number: 3003423869-2025-00012
• Device Sequence Number: 9560460
• Product Code: KPA
• UDI-Device Identifier: 05700571112571
• UDI-Public: (01)05700571112571(11)220301
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: 02/03/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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