MAUDE Adverse Event Report: DAKO DENMARK APS DAKO OMNIS

Model Number	GI100
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the source of the smoke/fumes was confirmed to be due to the ups.This failure mode resulted in the release of non-toxic fumes from the ups.Failure mode description: no dako product malfunction was identified after completion of investigation.Therefore, the failure mode could not be verified as a dako instrument or product specific malfunction.This report is being filed as part of agilent's commitment to due diligence reporting.
Event or Problem Description
Based on a recently logged complaint report on (b)(6) 2020, smoke/fumes were reported coming from a universal power supply (ups from powervar) attached to a dako omnis device within an anatomical pathology laboratory.The smoke/fumes triggered an "asthma-like attack" for one employee.In addition, three additional employees noted "breathing issues" but did not seek or require medical attention.The employee with the "asthma-like attack" sought medical attention but was able to returned to duty (did not require any absence from job).This event occurred during installation of a dako omnis, this unit was not running patient samples, so no patient testing or patient harm occurred.No serious harm to the user had occurred.

• Brand Name: DAKO OMNIS
• Common Device Name: DAKO OMNIS
• Manufacturer (Section D): DAKO DENMARK APS; produktionsvej 42; glostrup, 2600 ; DA 2600
• MDR Report Key: 10731012
• Report Number: 9610099-2020-00035
• Device Sequence Number: 16972095
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: GI100
• Device Catalogue Number: GI10030
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1