BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIRLIFE

    MDR report key: 2670686 · Received July 19, 2012

    Report

    Report Number
    2021710-2012-00069
    Event Type
    Other
    Date Received
    July 19, 2012
    Date of Event
    April 21, 2012
    Report Date
    April 21, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K050994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE USER FACILITY REP TO A CAREFUSION PRODUCT MANAGER. (B)(4). THE USER FACILITY REP IN CONJUNCTION WITH A CAREFUSION PRODUCT MANAGER DETERMINED THAT THE FOLLOWING ISSUES WERE CONTRIBUTING FACTORS IN THE ROOT CAUSE OF THE REPORTED EVENT: THE USER FACILITY IS TREATING SMALLER INFANTS DOWN TO 600 GRAMS WITH NCPAP. THE USER FACILITY HAS NEW NURSES AND RESPIRATORY THERAPISTS AND THERE HAS BEEN NO RECENT TRAINING IN THE PROPER APPLICATION TECHNIQUES OF THE AIRLIFE SERIES NCPAP SYSTEM (GENERATOR, MASK, PRONGS AND HEADGEAR).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT AND CONDITION OF THE PT WAS COPIED FROM AN E-MAIL FROM A CAREFUSION PRODUCT MANAGER. "STAGE 3 PRESSURE ULCER ON NOSE AND SEPTUM." "ON NASAL CPAP FOR 3 MONTHS, SKIN IRRITATION STARTED TO APPEAR WITHIN THE FIRST WEEK OF USE; USED THE SMALL PRONGS ALTERNATING WITH THE SMALL MASKS; SWITCHED ONE INFANT OVER TO HFNC. [NAME REMOVED] STATED ACCORDING TO THE SIZING GUIDE, THE SMALL PRONGS WERE TOO BIG FOR THE INFANTS NARES." "NO SURGICAL REPAIR REQUIRED, BOTH NASAL AREAS HAVE HEALED OVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) / BZD BZD CAREFUSION AIRLIFE NCPAP SYSTEM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ASKU