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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPING EXPRESS 4; STATSPIN CENTRIFUGE
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IRIS INTERNATIONAL STATSPING EXPRESS 4; STATSPIN CENTRIFUGE Back to Search Results
Catalog Number X00-00531-001
Device Problems Failure To Service (1563); Inappropriate/Inadequate Shock/Stimulation (1574); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 02/18/2014
Event Type  malfunction  
Event Description
The customer received an electric shock when removing tubes.Customer stated the unit starts upon power-up event with the lid opened.
 
Manufacturer Narrative
Statspin centrifuge reportedly gave a electric shock of unk intensity, but no injuries reported as a result.The operator who was shocked did not seek medical attention and did not report any burns of skin of finger.The unit started initiating spin even with lid open upon powering on.A lifted ground leakage current of 350ua was observed.The unit failed to trip a gfci (ground fault circuit interrupter) outlet.
 
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Brand Name
STATSPING 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
8185277497
MDR Report Key3721296
MDR Text Key20358554
Report Number2023446-2014-00027
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 02/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberX00-00531-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2008
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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