BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIRLIFE NCPAP SYSTEM

    MDR report key: 1004329 · Received February 4, 2008

    Report

    Report Number
    MW4004330
    Event Type
    Other
    Date Received
    February 4, 2008
    Date of Event
    October 25, 2007
    Report Date
    December 11, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BZD
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AUDABLE ALARM ON AIRLIFE NCPAP SYSTEM ALARMING AND VISUAL SCREEN REQUESTED PT BE REMOVED FROM DEVICE. BABY HAVING DESSATS AND REQUIRED RE-INTUBATION. UNABLE TO DUPLICATE PROBLEM WITH EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE NCPAP SYSTEM NCPAP SYSTEM BZD CARDINAL HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other