MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. DAKO OMNIS

Model Number	GI100
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complaint record reported the event as follows: external ups for workstation caught on fire.An autostainer ups was used with an omnis device.Lab removed power from the ups and put out the small flame.The site has replaced the ups with a new one.No direct or indirect patient harm or user harm have been reported.

• Brand Name: DAKO OMNIS
• Common Device Name: DAKO OMNIS
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, 76892 3; SN 768923
• MDR Report Key: 11227315
• Report Number: 3003423869-2021-00047
• Device Sequence Number: 11727730
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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: 04/15/2020
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1