BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-LO 6.5MM

    MDR report key: 1587189 · Received January 14, 2010

    Report

    Report Number
    2936999-2010-00076
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 15, 2009
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT HE RECEIVED INFO THAT A CUFF WOULD NOT DEFLATE, AND THE REPORTING HOSPITAL DID NOT RETAIN THE TUBE. NO OTHER INFO REGARDING ANY PT INVOLVEMENT OR USE REQUIRING INTERVENTION WAS CONTAINED IN THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-LO 6.5MM ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1