MalfunctionBZM
MEDGRAPHICS PFDX
Received Dec 23, 1998 · Event occurred Aug 19, 1998
Report MW1015286 · MDR key 203476
Device
Generic name
Pulmonary Function Test Equipment
Manufacturer
Medical Graphics CorporationModel number
DEMAND VALVE - G500Catalog number
*
Lot number
*
Product problems
- Valve(s), defective
Patient
28 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DURING A COMPLETE PULMONARY FUNCTION TEST, THE DEMAND VALVE MALFUNCTIONED, ALLOWING TANK PRESSURE TO BE DELIVERED TO PT.