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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTL EXPRESS 4; STATSPIN CENTRIFUGE
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IRIS INTL EXPRESS 4; STATSPIN CENTRIFUGE Back to Search Results
Catalog Number X00-005531-001
Device Problems Melted (1385); Smoking (1585); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 12/29/2014
Event Type  malfunction  
Event Description
Customer reported that the unit was hot and did not run.
 
Manufacturer Narrative
Customer reported that the unit was getting 'hot on the bottom' and producing wrench light errors.There was no report of smoke, fires, or burning and the fire dept was not called.There were no injuries reported or any exposure to thermal surfaces.The unit was sent to the mfr.Upon inspection, it was confirmed that the connector to pcb was burned.
 
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Brand Name
EXPRESS 4
Type of Device
STATSPIN CENTRIFUGE
Manufacturer (Section D)
IRIS INTL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277272
MDR Report Key4483446
MDR Text Key5561962
Report Number2023446-2015-00008
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
Remedial Action Notification
Type of Report Initial
Report Date 12/29/2013
1 Device was Involved in the Event
1 Patient was 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 NumberX00-005531-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
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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