OtherFII
MDR event
Received Aug 20, 2008
Report 9616240-2008-00043 · MDR key 1140024
Device
Product problems
- Normal
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Death
Narrative
Additional Manufacturer Narrative
NEITHER THE FACILITY'S CHARGE NURSE NOR THE CLINIC PHYSICIAN SUSPECT THIS PHOENIX MACHINE CAUSED OR CONTRIBUTED IN ANYWAY TO THE DEATH OF THIS PT. THIS EVENT IS BEING REPORTED AS PER GAMBRO POLICY: ALL CASES OF PT DEATH WITHIN 24 HOURS AFTER END OF THE TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE.