MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. ARTISAN LINK PRO

Model Number AR310

Device Problem Fire (1245)

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

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: all dako equipment impacted by the laboratory was moved following extinguishing of the fire.The equipment in the lab remains secure on site, while the local authorities complete their investigation.At this time, the fire department investigation report has not been released, thus the source of the fire has not been determined.Any new information, relevant to the root cause will be provided via a supplemental report.Failure mode description: as the investigation is ongoing, no malfunction has been currently identified.The failure mode cannot be verified as an instrument or product specific malfunction.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.

Event Description

Based on a recently logged complaint report, a fire was reported within an anatomical pathology laboratory.At this time, the source of the fire is unknown, but origination of fire occurred at the wiring behind the artisan per customer.The event occurred outside of the laboratory's normal hours of operation and no hospital personnel were injured due to this event.The customer complaint record reported the event as follows: an artisan burned due to fire in the lab.Following the event, the laboratory space was remediated and returned to operation.This resulted in a one business day delay in patient testing.No direct or indirect patient harm or user harm have been reported.

• Brand Name: ARTISAN LINK PRO
• Type of Device: ARTISAN LINK PRO
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer (Section G): 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: 11276480
• MDR Text Key: 230182574
• Report Number: 3003423869-2021-00115
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• 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: 09/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1