MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC ARTISAN LINK PRO

Model Number AR310

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2020

Event Type  malfunction  

Event Description

Summary: based on complaint report and investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: failed to stain slides on multiple occasions.No direct or indirect patient harm or user harm has been reported.

• Brand Name: ARTISAN LINK PRO
• Type of Device: ARTISAN LINK PRO
• Manufacturer (Section D): DAKO NORTH AMERICA, INC; 6392 via real; carpinteria, ca, ca
• Manufacturer (Section G): DAKO DENMARK APS; produktionsvej 42; glostrup, 2600 ; DA 2600
• Manufacturer Contact: thiago lima ; produktionsvej 42; glostrup, 2600 ; DA 2600
• MDR Report Key: 10287966
• MDR Text Key: 200618562
• Report Number: 2022180-2020-00010
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2020
• 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
• Patient Outcome(s): Other