MalfunctionBZM
SENSORMEDICS
Received Aug 19, 1999
Report MW1016971 · MDR key 237110
Device
Generic name
Pulmonary Function Analyzer
Manufacturer
Sensor Medics Corp.Model number
VMAX 229Catalog number
*
Lot number
*
Product problems
- Incorrect Measurement
- Repair
- Replace
- Other (for use when an appropriate device code cannot be identified)
- Low Readings
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
SENSORMEDICS VMAX 229 PULMONARY FUNCTION SYSTEM CONSISTENTLY UNDERESTIMATES THE LUNG VOLUME DETERMINATION IN PTS WITH COPD. SYSTEM USES NITROGEN WASHOUT METHOD TO MEASURE LUNG VOLUME. REPLACED MODULES AND RECEIVED SOFTWARE UPGRADE WITH NO CHANGE IN RESULTS.