inforMED
MalfunctionKSO

MTS 24 PLACE CENTRIFUGE

Received Oct 5, 2007 · Event occurred Sep 7, 2007

Report 1056600-2007-00282 · MDR key 924335

Device

Generic name

Centrifuge

Model number

NA

Catalog number

MTS515060

Lot number

NA

Product problems

  • Material Frayed
  • Insulation degradation
  • Wire(s), breakage of

Patient

YR

  • No Patient Involvement

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT, THE RETRACTILE CABLE OF THE MTS CENTRIFUGE IS FRAYED. INNER WIRES HAVE TORN INSULATION AND BLACK INNER WIRE IS BROKEN. THE CUSTOMER INDICATED THAT THE ISSUE WAS DISCOVERED DURING ROUTINE YEARLY MAINTENANCE. AN EXPOSED OR BROKEN WIRE MAY HAVE THE POTENTIAL FOR ELECTRICAL SHOCK OR FIRE.

Additional Manufacturer Narrative

THE CUSTOMER WAS INSTRUCTED BY OCD CUSTOMER TECHNICAL SERVICES (CTS) TO DISCONTINUE THE USE OF THE INSTRUMENT. THE REPLACEMENT RETRACTILE CABLE PART NUMBER WAS PROVIDED TO THE CUSTOMER. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT. PRODUCT LABELING CAUTIONS THE USER OF THE RISK OF ELECTRIC SHOCK INVOLVED IN SERVICING THE INSTRUMENT. PRODUCT LABELING PROVIDES THE USER WITH THE PROPER PROCEDURE TO FOLLOW WHEN REPAIRS ARE NECESSARY. THE ROOT CAUSE FOR THE DAMAGED WIRE IS UNKNOWN.