MalfunctionHCS
REUSABLE HEATER WIRE
Received Feb 21, 2007
Report 9611451-2007-00036 · MDR key 837443
Device
Generic name
*
Manufacturer
Fisher & Paykel Healthcare Ltd.Model number
900MR510Catalog number
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Lot number
*
Product problems
- Component(s), broken
- Device Damaged Prior to Use
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
CONCLUSIONS: NO CONCLUSION CAN BE MADE AT THIS TIME. THE DEVICE IS REUSABLE; HOWEVER, WE DO NOT KNOW WHETHER THE PROBLEM WAS DISCOVERED IN USE.
Description of Event or Problem
A HOSPITAL IN ANOTHER COUNTRY REPORTED THAT THE PLASTIC PART OF THE 900MR510 HEATER WIRE ASSEMBLY WAS DAMAGED AND BROKEN. ACCORDING TO THE HOSPITAL, THE CLEANING OF THE 900MR510 HEATER WIRE AT 75 DEGREE CELSIUS AND SUBSEQUENT STERILIZATION, AT 55 DEGREE CELSIUS USING ETHYLENE OXIDE GAS STERILIZING COULD HAVE BEEN A CONTRIBUTORY CAUSE.