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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL EXPRESS 3; STATSPIN CENTRIFUGE
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IRIS INTERNATIONAL EXPRESS 3; STATSPIN CENTRIFUGE Back to Search Results
Catalog Number X00-005222-001
Device Problems Melted (1385); Smoking (1585); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/19/2015
Event Type  malfunction  
Event Description
The customer reported a cracked lid and a burning smell on their statspin express 3.
 
Manufacturer Narrative
The customer reported a cracked lid and a burning smell on their statspin express 3.There was no report of operator injury or affect to patient samples.The fire department was not called.The unit is being returned to beckman coulter for further evaluation.Upon inspection chu identified a burned pcb assembly.
 
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Brand Name
EXPRESS 3
Type of Device
STATSPIN CENTRIFUGE
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
gopal mohanty
9172 eton ave.
chatsworth, CA 91311
8185277379
MDR Report Key4504222
MDR Text Key5442973
Report Number2023446-2015-00016
Device Sequence Number1
Product Code JQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberX00-005222-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2007
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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