MalfunctionCAP
AIRWAY PRESSURE MONITOR
Received Sep 12, 1997 · Event occurred Aug 13, 1997
Report 2518422-1997-00019 · MDR key 119185
Device
Generic name
Airway Pressure Monitor
Manufacturer
Respironics, Inc.Model number
332259Catalog number
332259
Lot number
NA
Product problems
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING EVALUATION AND REPAIR OF RETURNED DEVICE, IT WAS NOTED THAT THE LOW ALARM WOULD NOT TRIGGER UNTIL THE GAUGE WAS IN THE NEGATIVE RANGE, AT ABOUT -10. THE CUSTOMER WAS THEN CONTACTED FOR FURTHER INFO. THE CUSTOMER INDICATED THAT THE PROBLEM WAS DISCOVERED DURING THEIR INTERNAL TESTING. THE DEIVICE WAS NOT BEING USED BY A PT AT THE TIME.
Remedial action
- Repair