BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE

    MDR report key: 2000008 · Received February 17, 2011

    Report

    Report Number
    2183502-2011-00037
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 15, 2011
    Manufacturer
    SMITHS MEDICAL INTL, LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 1 HOUR IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE TRACHEOSTOMY TUBES JOH SMITHS MEDICAL INTL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK