PRESSURE ALARM
Received Dec 5, 2012 · Event occurred Nov 13, 2012
Report 2518422-2012-02411 · MDR key 2862196
Device
Generic name
Ventilatory, 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
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED BY THE MANUFACTURER. THE MANUFACTURER FOUND THE BATTERY CONTACTS TO BE BROKEN NOT ALLOWING THE 9 VOLT BATTERY TO BE INSERTED INTO THE DEVICE. THE DEVICE WOULD NOT OPERATE ON BATTERY POWER BUT WOULD OPERATE AS DESIGNED ON AC POWER. A FAILURE OF THE PRESSURE ALARM WOULD NOT AFFECT ANY CONNECTED DEVICE'S PRIMARY ALARMS OR FUNCTION. THE CONNECTED DEVICE (THE VENTILATOR) WOULD CONTINUE TO PROVIDE THERAPY AND AUDIBLY ALARM AS DESIGNED.
Description of Event or Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PRESSURE ALARM WAS NOT WORKING PROPERLY WHEN CONNECTED TO A VENTILATOR. THERE WAS NO REPORT OF HARM OR INJURY.