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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL EXPRESS 4; STATSPIN CENTRIFUGE
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IRIS INTERNATIONAL EXPRESS 4; STATSPIN CENTRIFUGE Back to Search Results
Catalog Number X00-005531-001
Device Problems Melted (1385); Smoking (1585); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/12/2015
Event Type  malfunction  
Event Description
Customer reported burning smell and noise from their express 4 unit.
 
Manufacturer Narrative
Customer reported a burnt plastic odor and a grinding noise from their statspin express 4.There were no reports of exposure or injury to the operator or any impact on centrifuged samples.There was no fire and the fire dept was not called.Customer technical support (cts) instructed the customer remove the bowl and inspect the power harness and pcb.The customer identified a blacked and discolored power harness connector to the pcb.
 
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Brand Name
EXPRESS 4
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 Key4611959
MDR Text Key5764190
Report Number2023446-2015-00051
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 Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial
Report Date 02/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberX00-005531-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2010
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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