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

Model Number AR310

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 329427604
• Report Number: 3003423869-2023-00102
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: 05700571108451
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR310
• Device Catalogue Number: AR31030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1