MalfunctionCAP
AIRWAY PRESSURE MONITOR
Received Nov 7, 1997 · Event occurred Oct 8, 1997
Report 2518422-1997-00024 · MDR key 131053
Device
Generic name
Airway Pressure Monitor
Manufacturer
Respironics, Inc.Model number
332259Catalog number
332259
Lot number
NA
Product problems
- Alarm, failure of warning
Patient
NA
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE ALARM WAS NOT SOUNDING. CUSTOMER INDICATED THAT THE DEVICE WAS BEING USED ON A PATIENT AT THE TIME OF THE ALLEGED PROBLEM, AND THAT THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Remedial action
- Repair