BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI

    MDR report key: 499489 · Received December 8, 2003

    Report

    Report Number
    499489
    Event Type
    Malfunction
    Date Received
    December 8, 2003
    Date of Event
    November 16, 2003
    Report Date
    November 18, 2003
    Manufacturer
    HUDSON RCI
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VERTICAL BREAK ON FI02 ADJUSTMENT COLLAR. THIS COULD RESULT IN PROBLEMS WITH DILUTING FI02 AT HIGHER FI02 SETTINGS IF NOT DETECTED PRIOR TO SETUP. APPARENTLY, THIS IS A RECURRING PROBLEM AS IT HAS BEEN NOTED ON OTHER OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON RCI NEBULIZER ADAPTOR CAF HUDSON RCI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other