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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. DAKO OMNIS
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AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. DAKO OMNIS Back to Search Results
Model Number GI100
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2020
Event Type  malfunction  
Event 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.
 
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Brand Name
DAKO OMNIS
Type of Device
DAKO OMNIS
Manufacturer (Section D)
AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
no.1 yishun avenue 7
singapore north east, 76892 3
SN  768923
Manufacturer (Section G)
AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
no.1 yishun avenue 7
singapore north east, 76892 3
SN   768923
Manufacturer Contact
sonia siddique
1834 tx-71 w
cedar creek, TX 78612
5123328112
MDR Report Key11227315
MDR Text Key228602243
Report Number3003423869-2021-00047
Device Sequence Number1
Product Code KPA
UDI-Device Identifier05700573004904
UDI-Public05700573004904
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGI100
Device Catalogue NumberGI10030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2020
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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