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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 Device Emits Odor (1425); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2014
Event Type  malfunction  
Event Description
Customer stated their express 4 unit had burnt interconnect cable to the pcb and was not working.
 
Manufacturer Narrative
Statspin centrifuge reported express 4 unit showing charred material (burnt interconnect cable to the pcb board).No injuries reported nor change to patient specimen as a result.When asked, no fires or smoke was observed.Since customer had broken the warranty seal, the unit could not be under warranty anymore.
 
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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
sudha gupta
9172 eton avenue
chatsworth, CA 91311
8185277272
MDR Report Key3886272
MDR Text Key4429815
Report Number2023446-2014-00039
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 03/13/2014
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 NumberX00-005531-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2014
Initial Date FDA Received04/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2010
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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