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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 Charred (1086); Device Emits Odor (1425); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 11/12/2014
Event Type  malfunction  
Event Description
Customer reported a burning smell and motor not running from the unit.
 
Manufacturer Narrative
Customer reported a defective motor and a burning smell from their centrifuge.There were no fire or smoke, or any injury to the operator, and no impact to pt results.The fire dept was not called.The unit was returned to the mfr.Mfr's inspection of the device confirmed the burning smell and a burnt pcb component.This burned/melted electronic compartment was identified as the cause of the burning smell.No injuries reported.No reports of visible flame nor fire dept being called, however, there is an evidence of charred electronic components.
 
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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
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277272
MDR Report Key4349450
MDR Text Key5179738
Report Number2023446-2014-00188
Device Sequence Number1
Product Code JQC
Combination Product (y/n)N
Reporter Country CodeUS
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 11/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/12/2014
Initial Date FDA Received12/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2009
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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