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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 Charred (1086); Failure To Service (1563)
Patient Problem No Patient Involvement (2645)
Event Date 02/19/2014
Event Type  malfunction  
Event Description
Customer reported the power harness burnt.
 
Manufacturer Narrative
It was reported the power connector to main control board was burned on the express 4 unit.The steady wrench light on the unit was due to the unit reaching 50,000 cycles.There was no reports of injuries, open flames, smoke emission, burnt smell, or fire department being called.
 
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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 ave.
chatsworth, CA 91311
8185277272
MDR Report Key4092835
MDR Text Key4716637
Report Number2023446-2014-00133
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 02/19/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2014
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberFA-14002
Patient Sequence Number1
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