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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER
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IRIS INTERNATIONAL ICHEM VELOCITY; AUTOMATED URINE CHEMISTRY ANALYZER Back to Search Results
Catalog Number 700-7177-001
Device Problems Charred (1086); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2012
Event Type  malfunction  
Event Description
Customer reported an error "heater failure" popped up.
 
Manufacturer Narrative
"heater failure" error was reported on ichem velocity.Field service engineer (fse) observed that the tubing connected to the dry pump had melted around the wiring harness for the doser fluidic system.Fse replaced the three connectors on the heater board, the dry pump and the board.Fse completed velocity performance verification checklist and customer ran specimens without any issues.System was operational.There were no reports of injuries, visible flames, smoke emission, and the fire department was not called.
 
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Brand Name
ICHEM VELOCITY
Type of Device
AUTOMATED URINE CHEMISTRY ANALYZER
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277272
MDR Report Key4272844
MDR Text Key21721557
Report Number2023446-2014-00162
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101852
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 12/19/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2014
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 Received12/19/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2011
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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