inforMED
MalfunctionCAP

AIRWAY PRESSURE MONITOR

Received Apr 24, 1997 · Event occurred Mar 24, 1997

Report 2518422-1997-00005 · MDR key 86339

Device

Generic name

Airway Pressure Monitor

Manufacturer

Respironics, Inc.

Model number

332259

Catalog 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

THE ALARM WAS NOT WORKING. 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