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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY URINE ANALYZER
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IRIS INTERNATIONAL ICHEM VELOCITY URINE ANALYZER Back to Search Results
Catalog Number 700-7177-001
Device Problems Device Operates Differently Than Expected (2913); Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2013
Event Type  malfunction  
Event Description
Customer reported that they were getting rack id errors on the ichem velocity instrument.
 
Manufacturer Narrative
Upon review of the instrument, charred material was found on the rack id board.It is suspected that canned air was used while running the instrument with power on.Customer was advised to avoid using canned air when power is applied.Velocity performance verification checklist was performed and controls were re-ran.System was operational.
 
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Brand Name
ICHEM VELOCITY URINE ANALYZER
Type of Device
ICHEM VELOCITY
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277497
MDR Report Key3750478
MDR Text Key4548800
Report Number2023446-2014-00005
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 11/07/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2014
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 Received11/07/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2011
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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