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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INT'L ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER

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IRIS INT'L ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER Back to Search Results
Catalog Number 700-7177-001
Device Problems Circuit Board (427); Altitude variations (1026); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2013
Event Type  Malfunction  
Event Description

Customer stated the velocity lever was not functioning and after multiple restarts the instrument was hot to touch.

 
Manufacturer Narrative

Customer stated the velocity lever was not functioning properly. After multiple attempts to restart the instrument the instrument became hot to the touch. There were no reports of smoke or fire, the fire dept was not called and there were no injuries. There were no reported affects to pt samples. Iris field svc engineer (fse) was sent to the customer location. The fse replaced mec board to the home sensor and resolved the customer issue. System verification was performed and passed. The system was operational.

 
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Brand NameICHEM VELOCITY
Type of DeviceAUTOMATED URINE CHEMISTRY ANALYZER
Manufacturer (Section D)
IRIS INT'L
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4748988
MDR Text Key5770855
Report Number2023446-2015-00146
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 03/23/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2015
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 Received03/23/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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