BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERFLEXX, RESCUE RED

    MDR report key: 12052680 · Received June 23, 2021

    Report

    Report Number
    1523574-2021-00007
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    February 8, 2021
    Report Date
    June 23, 2021
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, PER FDA REPORT # MW5101531 RECEIVED 6/15/21, AN INCIDENT OCCURING ON (B)(6) 2021 IN WHICH THE MEDIC CREW HAD LOADED THE STRETCHER AND PATIENT INTO THE AMBULANCE WHEN ONE OF THE MEDIC'S NOTICED THE PATIENT'S LEGS WERE NOT RESTRAINED. THEY APPLIED THE LEG RESTRAINT TO THE PATIENT, BUT FAILED TO NOTICE THE RESTRAINT WAS CAUGHT UNDER THE STRETCHER LEG. WHEN THE OPERATOR'S LOWERED THE STRETCHER, IT ALLOWED THE RESTRAINT TO CREATE EXCESSIVE PRESSURE ON THE PATIENT'S LEGS WHICH RESULTED IN THE PATIENT SUSTAINING SOFT TISSUE DAMAGE AND A HEMATOMA. THE CUSTOMER REPORTED THE COT WAS EVALUATED AND RETURNED TO SERVICE HOWEVER; NO DETAILS OF THE EVALUATION WERE PROVIDED. THE CUSTOMER REPORTED FINDING THE OPERATORS INCORRECTLY RESTRAINED THE PATIENT LEGS AND ADVISED THIS WAS A USE ERROR. PROPER INSTRUCTIONS FOR HOW TO RESTRAIN A PATIENT, CAN BE FOUND IN THE IFU. THE SERIAL # WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944104 POWERFLEXX, RESCUE RED POWERFLEXX, RESCUE RED FPO FERNO-WASHINGTON, INC. 0015651

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other