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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL EXPRESS 2; STATSPIN CENTRIFUGE
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IRIS INTERNATIONAL EXPRESS 2; STATSPIN CENTRIFUGE Back to Search Results
Catalog Number X00-003856-002
Device Problems Melted (1385); Smoking (1585); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 01/29/2015
Event Type  malfunction  
Event Description
Customer reported that the unit was not working and that there was smoke coming from their statspin express 2 centrifuge.
 
Manufacturer Narrative
There were no reports of exposure or injury to the operator or any impact on centrifuged samples.There was no fire and the fire department was not called.The unit was returned to the manufacturer for further evaluation, and a heat-damaged printed circuit board was identified as the cause of the burning smell.
 
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Brand Name
EXPRESS 2
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 Key4532016
MDR Text Key15114463
Report Number2023446-2015-00026
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
Type of Report Initial
Report Date 01/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberX00-003856-002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2003
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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