BEUDAMED
    FDA Adverse Event Summary report: N

    35X PROFLEXX AMBULANCE COT

    MDR report key: 6132487 · Received November 29, 2016

    Report

    Report Number
    1523574-2016-00035
    Date Received
    November 29, 2016
    Date of Event
    November 13, 2016
    Report Date
    January 30, 2017
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790000332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COT WAS RETURNED TO MANUFACTURER AND A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED. THE OVERALL CONDITION OF THE COT WAS VERY GOOD AND SHOWED SIGNS OF VERY LITTLE USE. THE WHEEL LOCKS ON THE COT WERE CYCLED WITH NO MALFUNCTIONS OR OTHER ISSUES DETECTED. WHEN THE BRAKES WERE ENGAGED THEY WERE ALL THE WAY LOCKED AND THERE WERE NO WORN AREAS THAT WOULD ALLOW A PARTIAL LOCK. THE IFU FOR THE COT PROVIDES INSTRUCTION ON ENGAGING THE LOCKS AS WELL AS NOT LEAVING THE COT UNATTENDED WHEN A PATIENT IS LOADED. UPON REVIEW OF THE INVESTIGATION, IT APPEARS THE MEDIC LEFT THE COT UNATTENDED AND THEN COULD NOT MAINTAIN CONTROL OF THE COT WHEN IT STARTED TO ROLL. IT COULD NOT BE DETERMINED IF THE BRAKE WAS COMPLETELY ENGAGED AT THE TIME OF INCIDENT. THE COMPLAINANT DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING ALLEGED INJURY OR MEDICAL INTERVENTION FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER REMOVING THE PATIENT AND COT FROM THE AMBULANCE THE CREW ENGAGED THE STRETCHER LOCK AND THEN STEPPED AWAY FROM THE COT TO TURN THE AMBULANCE OFF. THE STRETCHER LOCK ALLEGEDLY DISENGAGED AND THE STRETCHER BEGAN TO ROLL. THE EMT ATTEMPTED TO CONTROL THE STRETCHER BUT DUE TO THE PATIENT'S WEIGHT WAS UNABLE TO HOLD THE STRETCHER AND IT TIPPED OVER WITH THE PATIENT. THE PATIENT WAS ASSESSED AND ALLEGEDLY COMPLAINED OF PAIN TO HER LEFT SHOULDER. THE CREW TRANSPORTED THE PATIENT INTO THE HOSPITAL AND ALERTED THE RECEIVING RN TO THE INCIDENT AND ALLEGATION OF PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER REMOVING THE PATIENT AND COT FROM THE AMBULANCE THE CREW ENGAGED THE STRETCHER LOCK AND THEN STEPPED AWAY FROM THE COT TO TURN THE AMBULANCE OFF. THE STRETCHER LOCK ALLEGEDLY DISENGAGED AND THE STRETCHER BEGAN TO ROLL. THE EMT ATTEMPTED TO CONTROL THE STRETCHER BUT DUE TO THE PATIENT'S WEIGHT WAS UNABLE TO HOLD THE STRETCHER AND IT TIPPED OVER WITH THE PATIENT. THE PATIENT WAS ASSESSED AND ALLEGEDLY COMPLAINED OF PAIN TO HER LEFT SHOULDER. THE CREW TRANSPORTED THE PATIENT INTO THE HOSPITAL AND ALERTED THE RECEIVING RN TO THE INCIDENT AND ALLEGATION OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781708 35X PROFLEXX AMBULANCE COT 35X PROFLEXX AMBULANCE COT FPO FERNO-WASHINGTON, INC. 0015710 00190790000332

    Patients

    Seq Age Sex Outcome Treatment
    1