BEUDAMED
    FDA Adverse Event Death Summary report: N

    KID-EZ PEDIATRIC

    MDR report key: 191343 · Received October 15, 1998

    Report

    Report Number
    2082643-1998-01337
    Event Type
    Death
    Date Received
    October 15, 1998
    Date of Event
    June 1, 1998
    Report Date
    October 14, 1998
    Manufacturer
    SUNRISE MEDICAL MPD
    Product Code
    INM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT CHILD WAS PLACED IN THE KART SYSTEM WITHOUT THE LAPBELT NOR TRANSIT HARNESS CONNECTED. CHILD WAS APPARENTLY SLEEPING AND SLIPPED DOWN CAUSING HARNESS TO PRESS AGAINST THE CHILD'S WINDPIPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KID-EZ PEDIATRIC CHAIR, W/CASTRES INM SUNRISE MEDICAL MPD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death