FDA Adverse Event Malfunction Summary report: N

AIRLIFE NCPAP DRIVER

MDR report key: 2143680 · Received June 24, 2011

Report

Report Number
2143680
Event Type
Malfunction
Date Received
June 24, 2011
Date of Event
April 23, 2011
Report Date
June 23, 2011
Manufacturer
CAREFUSION 211, INC.
Product Code
BZD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WI, US

Narratives

Description of Event or Problem · 1

THREE INFANT FLOW DRIVERS WERE IN USE AND IN THE SAME AREA OF OUR NICU. ALL THREE HAD DIFFICULTY MAINTAINING THE PROPER FRACTION OF INSPIRED OXYGEN (FIO2) LEVEL AT THE SAME TIME. THE FIO2 WAS SIGNIFICANTLY LOWER THAN THE SETTING. THERE MAY HAVE BEEN A FLUCTUATION IN THE PRESSURE FROM THE MEDICAL AIR WALL SUPPLY SOURCE. NO OTHER DEVICES FAILED AT THE TIME. CAREFUSION HAS PROVIDED MEDICAL AIR PRESSURE REGULATORS TO BE INSTALLED ON THE AIR INLET OF THE FLOW DRIVER UNITS. THESE REGULATORS PROVIDE A STEADY PRESSURE TO THE INFANT DRIVER AND ELIMINATE THE ISSUE WITH POOR FIO2 CONTROL DURING FLUCTUATIONS OF THE WALL SUPPLY PRESSURE. THREE AFFECTED DEVICES WERE PURCHASED IN 3 DIFFERENT YEARS (2009, 2010, 2011). RESPIRATORY THERAPISTS NOTED DEVICES WERE AUDIBLY AND VISUALLY ALARMING, HOWEVER, THEY DID NOT NOTE WHAT TYPE OF ALARM THE DEVICE WAS PRESENTING (E.G. LOW SUPPLY PRESSURE, ETC). WALL MOUNTED GAS SUPPLY AT THE FACILITY IS SET TO DELIVER AT 50 PSI. CLINICAL ENGINEERING WAS UNABLE TO RE-CREATE THE FAILURE. UPON SPEAKING WITH THE SALES REPRESENTATIVE REGARDING THE ISSUE, THEY RECEIVED INLINE PRESSURE REGULATORS THAT APPEARED TO REMEDY THE OBSERVED DEVICE PROBLEM.======================MANUFACTURER RESPONSE FOR INFANT FLOW DRIVER VENTILATION UNIT, AIRLIFE (PER SITE REPORTER)======================INSTALL PRESSURE REGULATORS ON THE MEDICAL AIR INLET.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AIRLIFE NCPAP DRIVER VENTILATOR, NON-CONTINUOUS (RESPIRATOR), DRIVER BZD CAREFUSION 211, INC. 6900 *
2 AIRLIFE NCPAP DRIVER VENTILATOR, NON-CONTINUOUS (RESPIRATOR), DRIVER BZD CAREFUSION 211, INC. 6900 *
3 AIRLIFE NCPAP DRIVER VENTILATOR, NON-CONTINUOUS (RESPIRATOR), DRIVER BZD CAREFUSION 211, INC. 6900 *

Patients

Seq Age Sex Outcome Treatment
1 * NO OTHER THERAPIES