FLOTEC FLOPAC REGULATOR
Received Oct 26, 2004 · Event occurred Jul 27, 2004
Report 1832475-2004-00004 · MDR key 904452
Device
Generic name
Pressure Regulator Intigrated With Cylinder Valve
Manufacturer
Flotec, Inc.Model number
FP4-XX-B05-7005T2Catalog number
FP4-XX-B05-7005T2
Lot number
M625000
Product problems
- Decrease in Pressure
Patient
NO INFO
- Low Oxygen Saturation
Narrative
Description of Event or Problem
DURING A PULM. REHAB SESSION PT ON STRESS TEST EXPERIENCED LOW SPO2 LEVELS WHEN OXYGEN CYLINDER RAN OUT OF OXYGEN. CONTENTS GAUGE SHOWED INACCURATE PRESSURE RESULTING IN CYLINDER TANK RUNNING OT OF OXYGEN BEFORE COMPLETION OF TEST.
Additional Manufacturer Narrative
GAUGE SHOWED AN INACCURATE PRESSURE AS PRESSURE IN CYLINDER TANK WAS REDUCED. CAUSE: DECAL RING WAS ASSEMBLED WITHOUT ADEQUATE DEBURN AND REQUIRED PRESET PROCESS DURING ASSEMBLY. PREVIOUSLY ISSUED CORRECTIVE ACTIONS HAS PREVENTED EVENTS SINCE THEY WERE PUT INTO PLACE. ADD'L STEPS: ECN ON USER INSTRUCTIONS AND TRANSFILLER INSTRUCTION CLARIFYING AND MODIFYING CHECKS ON FUNCTION OF GAUGE TO CHECK FOR DAMAGE AND/OR FUNCTION AND CALIBRATION.
Remedial action
- Other
- Inspection
- Repair