MAUDE Adverse Event Report: CAREFUSION AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYSTEM DRIVER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AIRLIFE CPAP GENERATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from customer will be included in a follow up report.At this time carefusion is waiting for components from customer for evaluation.(b)(4).

Event Description

The customer reported the pressures were not accurate on the airlife nasal continuous positive airway pressure (ncpap) system driver.The customer stated he was able to troubleshoot down to the transducers manifold which is not working correctly.The customer reported there was no patient involvement associated with this event.

• Brand Name: AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYSTEM DRIVER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5269045
• MDR Text Key: 32940110
• Report Number: 2021710-2015-02380
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE CPAP GENERATOR
• Device Catalogue Number: 006900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1