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

Model Number	AR310
Medical Device Problem Codes	Fire (1245); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.A1-a6: not applicable.No patient involvement.
Event or Problem Description
The spain customer reported "heaters are burnt." agilent field service engineer states that some heater control boards, heaters and cables suffered damage and emitted flames with smoke while the instrument was in operation.Fse serviced the instrument with replacement of affected parts and confirms that the samples were not affected and all users and surrounding items near the instrument were safe from any harm.Instrument is running and the customer was able to complete testing.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.
Additional Manufacturer Narrative
No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.A1-a6: not applicable.No patient involvement.While the exact root cause is unable to be confirmed, it is determined that this incident is due to one of two reasons.Either liquid leaked onto the heater control board due to an unknown cause, or the heater control board short circuited and overheated.Both situations are accounted for in agilent's risk documentation and remain adequate.This is an isolated incident.
Event or Problem Description
The spain customer reported "heaters are burnt." agilent field service engineer states that some heater control boards, heaters and cables suffered damage and emitted flames with smoke while the instrument was in operation.Fse serviced the instrument with replacement of affected parts and confirms that the samples were not affected and all users and surrounding items near the instrument were safe from any harm.Instrument is running and the customer was able to complete testing.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.

• Brand Name: ARTISAN LINK PRO SPECIAL STAINS 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: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 18243485
• Report Number: 3003423869-2023-00102
• Device Sequence Number: 12407686
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: 05700571108451
• 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: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 11/07/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2013
• 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