PRESSURE ALARM
Received Oct 10, 2012 · Event occurred Sep 19, 2012
Report 2518422-2012-02098 · MDR key 2785266
Device
Generic name
Ventilator, Continuous, Facility Use
Manufacturer
Respironics Inc.Model number
23001Catalog number
23001
Lot number
23001
Product problems
- Device Operates Differently Than Expected
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 WAS DAMAGED. THE DEVICE WOULD NOT WORK ON BATTERY POWER BUT WOULD OPERATE AS DESIGNED ON AC POWER. A FAILURE OF THE EXTERNAL 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. AWAITING ESTIMATE APPROVAL FROM CUSTOMER.