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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN MP; STATSPIN CENTRIFUGE
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IRIS INTERNATIONAL STATSPIN MP; STATSPIN CENTRIFUGE Back to Search Results
Catalog Number X00-003917-001
Device Problems Loss of Threshold (1633); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 07/29/2014
Event Type  malfunction  
Event Description
Customer reported a rotor breakage.
 
Manufacturer Narrative
A loud noise and rotor breakage was reported by the centrifuge.An infant pt sample was lost as a result leading to recollection of sample.It was reported that this delayed pt treatment; however, it is unk if there was any harm to the pt due to the delay.The pieces of rotor and pt sample were contained within the centrifuge and no injuries to user were reported.
 
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Brand Name
STATSPIN MP
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 Key4102691
MDR Text Key4758249
Report Number2023446-2014-00137
Device Sequence Number1
Product Code GKG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K920759
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 07/29/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberX00-003917-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2008
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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