MalfunctionHCS
900MR510 REUSABLE HEATER WIRE
Received Jan 17, 2007
Report 9611451-2007-00005 · MDR key 809012
Device
Generic name
*
Manufacturer
Fisher & Paykel Healthcare, Ltd.Model number
900MR510Catalog number
900MR510
Lot number
*
Product problems
- Crack
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
NO INFORMATION TO DATE. INVESTIGATION STILL UNDERWAY, NO RESULTS TO DATE. NO CONCLUSION CAN BE MADE AT THIS TIME.
Description of Event or Problem
THE HOSP REPORTED THAT THEY HAVE HAD 15 REUSABLE HEATER WIRE ASSEMBLIES THAT HAVE CRACKED AT THE V-NOTCH ON THE ELBOW CONNECTOR. (NOTE THE V-NOTCH IS PART OF THE CONNECTION PORT WHERE A TEMPERATURE / FLOW PROBE IS INSERTED).