MalfunctionKSO
MTS 24 PLACE CENTRIFUGE
Received Mar 20, 2008 · Event occurred Feb 27, 2008
Report 1056600-2008-00091 · MDR key 1018534
Device
Generic name
Centrifuge
Manufacturer
Micro Typing Systems, Inc.Model number
NACatalog number
MT515060
Lot number
NA
Product problems
- Output above Specifications
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE MTS 24 PLACE CENTRIFUGE WAS NOT IN SPECIFICATION. THE USER DETECTED THE ISSUE AND RETESTED USING AN ALTERNATE CENTRIFUGE PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED. INCORRECT CENTRIFUGATION SPEED OR TIME DURING TESTING, IF UNDETECTED, MAY LEAD TO ERRONEOUS TEST RESULTS.
Additional Manufacturer Narrative
NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED FOR THIS INCIDENT. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS UNIT SINCE THIS INCIDENT.