BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODKNIGHT 418G

    MDR report key: 1853835 · Received September 8, 2010

    Report

    Report Number
    9615679-2010-00004
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 20, 2010
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    BZD
    PMA / PMN Number
    K980365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REFUSED TO RETURN THE DEVICE FOR EVAL.

    Description of Event or Problem · 1

    COVIDIEN REC'D A REPORT FROM AN END USER ALLEGING THE INTERNAL FOAM INSULATION DISINTEGRATING AND POSSIBLE INHALATION OF FOAM MATERIAL. DURING THE PHONE CONVERSATION WITH END USER, IT WAS IDENTIFIED THAT THE DEVICE WAS IN CONTINUOUS USE FOR APPROX TEN YRS WITH NO APPROPRIATE EQUIPMENT MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODKNIGHT 418G GOODKNIGHT BZD NELLCOR PURITAN BENNETT 418

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK