MalfunctionCAP
AIRWAY PRESSURE MONITOR
Received May 14, 1997 · Event occurred Apr 14, 1997
Report 2518422-1997-00008 · MDR key 91070
Device
Generic name
Airway Pressure Monitor
Manufacturer
Respironics, Inc.Model number
332259Catalog number
332259
Lot number
NA
Product problems
- Device Inoperable
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DEVICE WAS BEING TESTED PRIOR TO USE ON A PATIENT AFTER BEING IN STORAGE FOR AN UNDETERMINED AMOUNT OF TIME. TESTING BY THE FACILITY INDICATED THAT SERVICING WAS REQUIRED ON THE DEVICE BECAUSE OF "NO LOW ALARM CONTROL, AND A MISSING RING FROM THE SWITCH." DEVICE WAS RETURNED FOR SERVICING. DURING SERVICING, IT WAS DETERMINED THAT THE ALARM WAS NOT FUNCTIONAL. DEVICE WAS NOT ON A PATIENT AT THE TIME OF THE REPORTED PROBLEM.
Remedial action
- Repair