HYPERBARIC VENTILATOR
Received Feb 1, 2013 · Event occurred Jan 4, 2013
Report 2020676-2013-00001 · MDR key 2971114
Device
Generic name
Ventilator, Continuous, Facility Use
Manufacturer
Sechrist Industries, Inc.Model number
500ACatalog number
3000
Product problems
- Pressure Problem
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
THE REPORTED FAILURE WAS VERIFIED AND DUPLICATED. EVALUATION OF THE DEVICE TOOK PLACE BY THE MANUFACTURER. THE EXHALATION KNOB TURNS PAST THE STOP DUE TO THE KNOB BEING SET AT THE INCORRECT HEIGHT. THIS ALLOWED THE KNOB TO SLIP PAST THE STOP PIN. FURTHER TESTING FOUND THAT THE MAXIMUM INHALATION AND EXHALATION TIMES AND THE MINIMUM INHALATION TIME WERE OUT OF SPECIFICATION. THE TIDAL VOLUME AT 1000 IS OUT OF SPECIFICATION AT 2.0ATA, 2.5ATA AND 3.0ATA. THE IMMEDIATE CAUSE OF THE INHALATION AND EXHALATION TIMES AND TIDAL VOLUME BEING OUT OF SPECIFICATION WAS A MALFUNCTIONING FLUIDIC INTERFACE.
Description of Event or Problem
A BIOMEDICAL TECHNICIAN FOR THE HOSPITAL REPORTED THAT DURING A SCHEDULED PERFORMANCE MAINTENANCE TEST IT WAS FOUND THAT THE VENTILATOR PRESURE DID NOT COMPENSATE FOR THE CHAMBER PRESSURE.