BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME BIG WHEEL

    MDR report key: 10372395 · Received August 6, 2020

    Report

    Report Number
    10372395
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    June 29, 2020
    Report Date
    August 3, 2020
    Manufacturer
    STRYKER CORPORATION
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RECEIVED SERVICE CALL TO REPAIR "STRETCHER - BRAKE PEDAL BROKEN, SPINS AROUND". WHEN A NURSE OR CAREGIVER PUSHES DOWN ON A THE PEDAL, IT CAN HAVE A TENDENCY TO BREAK. CAUSING THE PEDAL TO SPIN UPSIDE DOWN AN POTENTIALLY HITTING THE NURSE OR CAREGIVER'S FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837470 PRIME BIG WHEEL STRETCHER, WHEELED FPO STRYKER CORPORATION 1115

    Patients

    Seq Age Sex Outcome Treatment
    1