BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE EASY

    MDR report key: 370434 · Received January 4, 2002

    Report

    Report Number
    1417519-2001-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2002
    Report Date
    December 29, 2001
    Manufacturer
    IPI MEDICAL
    Product Code
    JYJ
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ENDOTRACHEAL TUBE CUFF BURST DURING INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE EASY CUFF PRESSURE MONITOR JYJ IPI MEDICAL * L225

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention