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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL EXPRESS 4; STATSPIN CENTRIFUGE JQC
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IRIS INTERNATIONAL EXPRESS 4; STATSPIN CENTRIFUGE JQC 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 12/08/2014
Event Type  malfunction  
Event Description
Customer reported smoke from the power connector and harness was brunt.
 
Manufacturer Narrative
The customer reported a burnt power harness on their statspin express 4.There were no reports of exposure or impact to operator or pt results and the fire department was not called.There was no reported impact to pt results as a result of this event.During the manufacturer phone troubleshooting, it was determined that the power harness was burnt.
 
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Brand Name
EXPRESS 4
Type of Device
STATSPIN CENTRIFUGE JQC
Manufacturer (Section D)
IRIS INTERNATIONAL
9172 eton ave.
chatsworth CA 91311
Manufacturer Contact
sudha gupta
9172 eton ave.
chatsworth, CA 91311
8185277272
MDR Report Key4365967
MDR Text Key5285608
Report Number2023446-2014-00196
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 12/08/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2014
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 Received12/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2012
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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