BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIRLIFE

    MDR report key: 2543092 · Received March 29, 2012

    Report

    Report Number
    2021710-2012-00021
    Event Type
    Other
    Date Received
    March 29, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K050994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. (B)(4) - NASAL PRONG BROKEN OFF OF NASAL PRONGS ASSEMBLY. THE ALLEGED BROKEN DEVICE WAS RECEIVED BY CAREFUSION ON (B)(6) 2012, ROUTED TO THE CARE FUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED BY A CAREFUSION TECH SUPPORT SPECIALIST FROM AN E-MAIL FROM A USER FACILITY REPRESENTATIVE THAT WAS FORWARDED BY A CAREFUSION PRODUCT MANAGER TO CAREFUSION TECH SUPPORT. "I WANTED TO REPORT TO YOU THAT WE HAD AN UNUSUAL EVENT HAPPEN ON (B)(6) NIGHT SHIFT. ONE OF OUR BABIES IS ON THE AIRLIFE NCPAP SYSTEM, AND WHILE THE NURSE WAS ADJUSTING THE INTERFACE AFTER NOTING THE PT WAS DESATURATING, SHE NOTICED THAT ONE OF THE PRONGS HAD COMPLETELY BROKEN OFF. IT BROKE AT THE PART WHERE THE PRONG IS GROOVED. THE PRONG WAS SAFELY RETRIEVED FROM THE BABY'S NARE. I HAVE NEVER SEEN THIS HAPPEN BEFORE, BUT IT COULD'VE REALLY COMPROMISED THE PT FURTHER IF THE PRONG GOT STUCK IN THE BABY'S NARE. I HAVE THE DEFECTIVE PRONG IN MY OFFICE. P.S. THIS WAS NOT AN OLD PRONG, IT HAD BEEN CHANGED THE DAY BEFORE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) /BZD BZD CAREFUSION SMALL NASAL PRONGS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU ASKU/ASKU