BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORTH AMERICAN RESCUE

    MDR report key: 19688789 · Received July 8, 2024

    Report

    Report Number
    3005034064-2024-00001
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 19, 2021
    Report Date
    June 3, 2024
    Manufacturer
    NORTH AMERICAN RESCUE, LLC
    Product Code
    FMR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBLEM IS USE ERROR. THIS IS THE ONLY ISSUE REPORTED FOR THIS PRODUCT. THE CUSTOMER REPORTED THAT, "THE INCIDENT OCCURRED AT A GRADED EVALUATION OF OUR MEDICAL RESPONSE TEAM. WE ARE GRADED BASED ON NUMBERS OF PATIENTS SEEN PER HOUR SO IT WAS HECTIC. THE WEATHER WAS EXTREMELY HOT AS WELL AND WE HAD SEVERAL PEOPLE GO DOWN WITH HEAT EXHAUSTION CAUSING DISTRACTIONS. THE INJURED PERSON WAS ONE OF OUR CRITICAL CARE NURSES WITH YEARS OF EXPERIENCE. IT WAS NOT HER FIRST TIME USING THE LITTER CARRIER. IT SEEMED TO BE AN UNFORTUNATE ACCIDENT. WE USE SAFETY GLOVES WHEN WE SET UP THE LITTER CARRIER BUT SWITCH TO SURGICAL GLOVES ONCE WE BEGIN PERFORMING OUR DUTIES. IN THIS CASE, WE HAD A VICTIM (ROLE PLAYER) ON THE LITTER. WHEN WE BEGAN TO MOVE THE PATIENT, THE LEG UNLOCKED AND THE NURSE REACHED DOWN WITH HER HAND TO LOCK IT PINCHING THE END OF HER FINGER IN THE JOINT OF THE LEG LOCK. SHE DID LOSE THE TIP OF HER FINGER BUT DID NOT HAVE BONE LOSS. WE TRAIN NOW TO USE OUR FEET TO LOCK THE LEG INSTEAD OF OUR HANDS. I DON'T HAVE A LOT NUMBER AND I DON'T BELIEVE IT WAS MECHANICAL FAILURE. WE RAISE THE LEG DURING TRANSPORT. I THINK THAT THE LEG WASN'T FULLY LOCKED ONCE THEY STARTED TREATING THE PATIENT."

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT "THEY HAD A SITUATION WITH THE WHEELED LITTER CARRIER ARM NOT BEING LOCKED IN PLACE WHILE TRANSPORTING A PATIENT. THE PERSON TRANSPORTING THE PATIENT WAS UNABLE TO SEE WHAT THEY WERE DOING AND TRIED TO LOCK THE ARM BACK IN PLACE AND MUST HAVE PUSHED DOWN ON THE WRONG SPOT AND HER FINGER BECAME PINCHED AND SHE LOST THE TIP OF HER FINGER." THIS WAS REPORTED TO NAR ON 5/8/24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152547 NORTH AMERICAN RESCUE WHEELED LITTER CARRIER FMR NORTH AMERICAN RESCUE, LLC 60-0041 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other