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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY; ICHEM VELOCITY URINE ANALYZER
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IRIS INTERNATIONAL ICHEM VELOCITY; ICHEM VELOCITY URINE ANALYZER Back to Search Results
Catalog Number 700-7177-001
Device Problems Thermal Decomposition of Device (1071); Component or Accessory Incompatibility (2897); Installation-Related Problem (2965)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2013
Event Type  malfunction  
Event Description
Ichem velocity automated urine chemistry analyzer reporting smoke, burning smell and charred mec board caused by 24v installation process (electrical).No injuries reported.Fire department was not called and there were no reports of any visible flames.
 
Manufacturer Narrative
Mec board burned out during 24v initialization.There was smoke and a burning smell coming from the mec cabinet area after the instrument was turned off.Inspection revealed that the mec board burned.Ran calcheck, precision and controls to complete installation.System is operational.
 
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Brand Name
ICHEM VELOCITY
Type of Device
ICHEM VELOCITY URINE ANALYZER
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277497
MDR Report Key3753736
MDR Text Key16595558
Report Number2023446-2014-00017
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 11/20/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number700-7177-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2013
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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