MalfunctionJRS
OSMONICS F801 RO SYSTEM
Received Oct 13, 2001
Report 3019131-2001-00001 · MDR key 356166
Device
Generic name
Reverse Osmosis Water Purification System For Hemodialysis.
Manufacturer
Osmonics, Inc.Model number
12340Catalog number
NA
Lot number
UNK
Product problems
- Collapse
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
USER FACILITY REPORTS THAT THE CASTERS ON THE MEDICAL DEVICE ARE "COLLAPSING" UNDER RIGOROUS USE. MEDICAL DEVICES ARE TRANSPORTED TO, AND USED AT, 13 SEPARATE FACILITIES.