STATSPIN SSVT-1 CENTRIFUGE X00-003917-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-28 for STATSPIN SSVT-1 CENTRIFUGE X00-003917-001 manufactured by Iris International.

Event Text Entries

[81328410] Customer technical specialist (cts) advised customer to return the unit. Customer returned ssvt - 1 centrifuge for investigation. Only the centrifuge was received, rotor was not returned. Upon visual inspection of the centrifuge, noted the hinge on the lid was broken. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[81328571] The customer reported the rt12 rotor broke during centrifugation of the statspin ssvt-1 centrifuge. The customer stated that the safety shield was in use at the time of the event. The customer stated that pieces of the rotor had escaped from the ssvt- 1 centrifuge. There are no reports of harm or injury, no customer exposure, and no medical attention was received due to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2023446-2017-00007
MDR Report Key6751302
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-07-28
Date of Report2017-07-17
Date of Event2017-07-05
Date Mfgr Received2017-07-17
Device Manufacturer Date2010-02-22
Date Added to Maude2017-07-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGOPAL MOHANTY
Manufacturer Street9172 ETON AVENUE
Manufacturer CityCHATSWORTH CA 91311
Manufacturer CountryUS
Manufacturer Postal91311
Manufacturer Phone8185277379
Manufacturer G1IRIS INTERNATIONAL
Manufacturer Street9172 ETON AVENUE
Manufacturer CityCHATSWORTH CA 91311
Manufacturer CountryUS
Manufacturer Postal Code91311
Single Use3
Previous Use Code3
Removal Correction NumberFA-24395
Event Type3
Type of Report3

Device Details

Brand NameSTATSPIN SSVT-1 CENTRIFUGE
Generic NameCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
Product CodeJQC
Date Received2017-07-28
Model NumberNA
Catalog NumberX00-003917-001
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerIRIS INTERNATIONAL
Manufacturer Address9172 ETON AVENUE CHATSWORTH CA 91311 US 91311


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-28

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