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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTL ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER

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IRIS INTL ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER Back to Search Results
Catalog Number 700-7177-001
Device Problems Tube (525); Melted (1385); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2012
Event Type  Malfunction  
Event Description

Customer reported 'heater failure' error on the unit.

 
Manufacturer Narrative

Customer reported 'heater failure' error on the unit. There were no injuries reported, nor any smoke emission, and fire dept was not called. The field service engineer (fse) observed the tubing above the dry pump appeared to be overheated and melted. Fse replaced the dry pump and the mec board. System was operational.

 
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Brand NameICHEM VELOCITY
Type of DeviceAUTOMATED URINE CHEMISTRY ANALYZER
Manufacturer (Section D)
IRIS INTL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277272
MDR Report Key4483438
MDR Text Key18627287
Report Number2023446-2015-00013
Device Sequence Number1
Product Code KQO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101852
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 12/20/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/29/2015
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 Received12/20/2012
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 Unkown

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