MalfunctionCAP
AIRWAY PRESSURE MONITOR
Received Apr 3, 1998 · Event occurred Mar 5, 1998
Report 2518422-1998-00003 · MDR key 161232
Device
Generic name
Airway Pressure Monitor
Manufacturer
Respironics, Inc.Model number
332259Catalog number
332259
Lot number
NA
Product problems
- Alarm, failure of warning
Patient
UNKNOWN
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
CUSTOMER RETURNED DEVICE FOR REPAIR INDICATING THAT THE "LOW PRESSURE ALARM WAS BROKEN." ACCORDING TO THE CUSTOMER, DEVICE WAS IN USE BY A PATIENT, BUT THERE WAS NO HARM TO THE PATIENT. NO FURTHER PATIENT INFO WAS PROVIDED.
Remedial action
- Repair