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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER
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IRIS INTERNATIONAL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER Back to Search Results
Catalog Number 700-3375
Device Problems Melted (1385); Smoking (1585); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/09/2014
Event Type  malfunction  
Event Description
Customer reported a smoke from the unit.
 
Manufacturer Narrative
Customer reported a smoke from the unit.Iris field service engineer (fse) found the backplane board and ssmb board burnt.The boards were replaced, but the issue was not resolved.A new replacement instrument was sent to the customer.No injuries and no visible flames were reported and the fire department was not called.
 
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Brand Name
IQ200
Type of Device
AUTOMATED URINE MICROSCOPY ANALYZER
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton avenue
chatsworth, CA 91311
8185277272
MDR Report Key4349796
MDR Text Key5200856
Report Number2023446-2014-00186
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K022774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-3375
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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