BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 148462 · Received February 11, 1998

    Report

    Report Number
    MW1012973
    Event Type
    Malfunction
    Date Received
    February 11, 1998
    Date of Event
    January 20, 1998
    Report Date
    February 4, 1998
    Manufacturer
    MONAGHAN MEDICAL CORP
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CHAMBER IS OUT OF ROUND & HAS A RIDGE PROBABLY RESULTING IN A STRESS FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * AEROCHAMBER WITH MEDIUM MASK CAF MONAGHAN MEDICAL CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other