MAUDE Adverse Event Report: DAKO DENMARK APS ARTISAN LINK PRO

Model Number AR310

Device Problem Temperature Problem (3022)

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

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: potential alteration of staining in this case was due to a faulty heater.The problem was solved by field service engineer with replacement of the part.Following service, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following heater malfunction, a slide or slides located at faulty heater location will not heat up to the desired temperature required for testing.This could lead to abnormal staining.These events can be caused by a heater/heater pcb/cable malfunction or a temperature misalignment needing calibration.

Event Description

Based on complaint report or investigated failure mode, there was potential for an alteration in staining.Customer complaint record reported the event as follows: 3 heaters don't reach temperature.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): DAKO DENMARK APS; produktionsvej 42; glostrup, 2600 ; DA
• Manufacturer (Section G): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria CA 93013
• Manufacturer Contact: benjamin gaither ; 6392 via real; carpinteria, CA 93013 ; 5123328207
• MDR Report Key: 10684503
• MDR Text Key: 211528638
• Report Number: 9610099-2020-00033
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): Y
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1