MAUDE Adverse Event Report: DAKO DENMARK APS DAKO OMNIS

Model Number GI100

Device Problem Smoking (1585)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/23/2020

Event Type  malfunction  

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 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
• Type of Device: DAKO OMNIS
• Manufacturer (Section D): DAKO DENMARK APS; produktionsvej 42; glostrup, 2600 ; DA 2600
• Manufacturer (Section G): DAKO DENMARK APS; produktionsvej 42; glostrup, 2600 ; DA 2600
• Manufacturer Contact: sonia siddique ; 6392 via real; carpinteria, CA 93013 ; 5123328112
• MDR Report Key: 10731012
• MDR Text Key: 212963906
• Report Number: 9610099-2020-00035
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GI100
• Device Catalogue Number: GI10030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• 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