MalfunctionBXY
PRECISION MEDICAL
Received Mar 8, 2010 · Event occurred Mar 5, 2010
Report 2523148-2010-00001 · MDR key 1627422
Device
Generic name
Oxygen Flow Selector
Manufacturer
Precision Medical, Inc.Model number
PM1000Catalog number
PM1000
Lot number
1209
Product problems
- Device Markings/Labelling Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
FLOW SELECTOR IS MISLABELED. SELECTOR CAN BE POSITIONED IN THE "ON" POSITION TO ADMINISTER OXYGEN AND REALLY BE IN THE "OFF" POSITION.
Additional Manufacturer Narrative
ADDITIONAL LOT #: 0110. FOUND THAT DEVICE IS MISLABELED ON TWO DIFFERENT LOTS 12/09 AND 01/10. DEVICE CAN APPEAR TO BE IN THE ON POSITION WHEN IT IS REALLY OFF.
Remedial action
- Replace
- Recall