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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 700-3320
Device Problems Charred (1086); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2015
Event Type  malfunction  
Event Description
Customer reported burning smell and smoke from their iq200 unit.
 
Manufacturer Narrative
Customer reported the probe stuck in position and a burning smell from their iq200 unit.No one was injured and no erroneous results were reported or generated.There was no report of smoke or fire.Fire department was not called in.An iris field service engineer (fse) replaced the burnt out boards and performed post repair alignment and qc passed successfully.System was operational.
 
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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
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4589789
MDR Text Key5342205
Report Number2023446-2015-00043
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
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 02/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-3320
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
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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