PRESSURE ALARM
Received Jul 11, 2012 · Event occurred Jun 18, 2012
Report 2518422-2012-01470 · MDR key 2654773
Device
Generic name
Ventilator, Continuous, Facility Use
Manufacturer
Respironics, Inc.Model number
23001Catalog number
23001
Product problems
- Device Alarm System
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE MFR RECEIVED INFO ALLEGING AN EXTERNAL PRESSURE ALARM WAS NOT WORKING PROPERLY WHEN CONNECTED TO A VENTILATOR. THERE WAS NO REPORT OF PT HARM OR INJURY.
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED BY THE MFR. THE MFR FOUND THE BATTERY CONNECTOR HARNESS WAS DAMAGED. THE DEVICE WOULD NOT WORK ON BATTERY POWER, BUT WOULD OPERATE AS DESIGNED ON AC POWER. A FAILURE OF THE VENTILATOR'S PRESSURE ALARM WOULD NOT AFFECT THE DEVICE'S PRIMARY ALARM OR FUNCTION. THE VENTILATOR WOULD CONTINUE TO PROVIDE THERAPY AND AUDIBLY ALARM FOR PT EVENTS.