BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 679992 · Received February 23, 2006

    Report

    Report Number
    2936999-2006-00073
    Event Type
    Malfunction
    Date Received
    February 23, 2006
    Date of Event
    February 17, 2006
    Report Date
    February 20, 2006
    Manufacturer
    JUAREZ HENEQUEN
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 02/2006, NELLCOR BENNETT RECEIVED A REPORT WHERE THE CUSTOMER STATED "THE BALLOON DID NOT INFLATE TOTALLY AND DID NOT DEFLATE TOTALLY." NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE BTO JUAREZ HENEQUEN FEN 0506002498

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN