BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN X, FOR INLINE

    MDR report key: 9110507 · Received September 24, 2019

    Report

    Report Number
    1523574-2019-00031
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 11, 2019
    Report Date
    October 24, 2019
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COT WAS EVALUATED BY AN AUTHORIZED TECHNICIAN. THE TECHNICIAN WAS UNABLE TO FIND ANY ISSUES WITH THE STRETCHER AND REPORTED IT AS WORKING AS INTENDED. THE FASTENER, HOWEVER, SUSTAINED DAMAGES INDICATIVE OF A HIGH SPEED IMPACT AND WAS NOT APPROVED FOR SERVICE. THE CUSTOMER HAS BEEN ADVISED TO REPLACE THE FASTENER DUE TO EXCESSIVE DAMAGES SUSTAINED. THE ROOT CAUSE OF THE DAMAGES TO THE FASTENER ARE ATTRIBUTED TO THE HIGH SPEED MOTOR VEHICLE ACCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED A FERNO STRETCHER WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND ALLEGEDLY BECAME DETACHED FROM THE FASTENER. SPEED AT IMPACT WAS REPORTED BETWEEN 70-80 MPH. THERE WAS NO PATIENT ON THE STRETCHER AT THE TIME OF THE ACCIDENT. THE SERIAL # OF THE STRETCHER OR FASTENER HAVE NOT BEEN PROVIDED AND HAVE NOT BEEN EVALUATED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ATTRIBUTED TO A HIGH SPEED MOTOR VEHICLE ACCIDENT AT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED A FERNO STRETCHER WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND ALLEGEDLY BECAME DETACHED FROM THE FASTENER. SPEED AT IMPACT WAS REPORTED BETWEEN 70-80 MPH. THERE WAS NO PATIENT ON THE STRETCHER AT THE TIME OF THE ACCIDENT. THE SERIAL # OF THE STRETCHER OR FASTENER HAVE NOT BEEN PROVIDED AND HAVE NOT BEEN EVALUATED BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907738 IN X, FOR INLINE IN X, FOR INLINE FPO FERNO-WASHINGTON, INC. 0015811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other