MTS 24 PLACE CENTRIFUGE MT515060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-12-17 for MTS 24 PLACE CENTRIFUGE MT515060 manufactured by Micro Typing Systems, Inc..

Event Text Entries

[20238062] The customer reported that the mts 24 place centrifuge was not spinning at the correct time. No erroneous results were reported. Incorrect centrifugation speed or time during testing, if undetected, may lead to erroneous test results.
Patient Sequence No: 1, Text Type: D, B5


[20608920] Ocd customer technical services (cts) advised the customer regarding their purchase options for a replacement unit since the centrifuge was out of warranty. This customer has not logged any complaints against this centrifuge since the incident. Incident is isolated.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1056600-2008-00364
MDR Report Key1279635
Report Source05,06
Date Received2008-12-17
Date of Report2008-12-17
Date of Event2008-11-24
Date Mfgr Received2008-11-24
Device Manufacturer Date1997-12-01
Date Added to Maude2009-06-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJENNIFER SPARROW
Manufacturer Street1001 US ROUTE 202
Manufacturer CityRARITAN NJ 08869
Manufacturer CountryUS
Manufacturer Postal08869
Manufacturer Phone9087043872
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMTS 24 PLACE CENTRIFUGE
Generic NameCENTRIFUGE
Product CodeKSO
Date Received2008-12-17
Model NumberNA
Catalog NumberMT515060
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMICRO TYPING SYSTEMS, INC.
Manufacturer Address1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US 33069


Patients

Patient NumberTreatmentOutcomeDate
10 2008-12-17

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