BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERGUARD EVAC 7.0

    MDR report key: 1925967 · Received November 10, 2010

    Report

    Report Number
    2936999-2010-01317
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 11, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE COVIDIEN OFFICE IN (B)(4) THAT A BRAND NAME VBN PRESSURE GAUGE WAS WORKING NON STOP BECAUSE, THE ENDOTRACHEAL TUBE'S CUFF COULD NOT MAINTAIN THE PRESSURE. AS THE VBN PRESSURE GAUGE WAS WORKING TO MAINTAIN THE CUFF PRESSURE, THE PATIENT WAS NOT EXTUBATED. THE CUSTOMER REPORTED THAT THESE ENDOTRACHEAL TUBE GENERALLY ARE NOT USED LONG TERM SO, THE JUST KEPT RE-INFLATING THE CUFFS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERGUARD EVAC 7.0 ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO HEALTHCARE 0903001400

    Patients

    Seq Age Sex Outcome Treatment
    1