MalfunctionCAP
AIRWAY PRESSURE MONITOR
Received May 14, 1996 · Event occurred Apr 26, 1996
Report 1317346-1996-00001 · MDR key 34078
Device
Generic name
Airway Pressure Monitor
Manufacturer
Monaghan Medical Corp.Model number
CM5000SCCatalog number
900-50SC-001
Lot number
Q583
Product problems
- Device Alarm System
- Use of Incorrect Control/Treatment Settings
- Misassembled
- Material Separation
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
AIRWAY PRESSURE MONITOR WAS REPORTED TO HAVE FAILED TO EXHIBIT LOW PRESSURE ALARM CONDITION WHEN PT CIRCUIT BECOME DISLODGED FROM THE TRACHEAL TUBE. AN ATTENDING THERAPIST RE-CONNECTED BREATHING CIRCUIT WITHOUT ANY FURTHER INCIDENT. DEVICE WAS NOT PROPERLY SET UP PRIOR TO OPERATION. UNIT WAS SUBSEQUENTLY SET UP ACCORDING TO MFR'S SPECS.