BEUDAMED
    FDA Adverse Event Injury Summary report: N

    93H PROFLEXX H FRAME COT

    MDR report key: 4891546 · Received July 6, 2015

    Report

    Report Number
    1523574-2015-00065
    Event Type
    Injury
    Date Received
    July 6, 2015
    Report Date
    September 4, 2015
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS EVALUATED BY THE MANUFACTURER. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED AND NO FAILURES WERE DETECTED AND THE ALLEGED INCIDENT COULD NOT BE DUPLICATED. THE COT HAS BEEN RETURNED TO THE CUSTOMER. A HISTORICAL REVIEW OF THE SERIAL NUMBER FOR THIS DEVICE WAS MADE AND IT REVEALED THERE HAVE BEEN NO PRIOR COMPLAINTS OR FIELD SERVICE WORK ORDERS ON THIS DEVICE IN ITS 5 YEAR LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE TRANSITION FROM TRANSPORT HEIGHT TO LOAD HEIGHT, THE STRETCHER ALLEGEDLY LOWERED AT THE FOOD END. THE FOOT END OPERATOR HELD ONTO THE STRETCHER SO THE PATIENT WOULD NOT BE JARRED AND ALLEGEDLY SUSTAINED A BACK INJURY. THE EMT DID SEEK MEDICAL ATTENTION AND HAD 2 DAYS LIGHT DUTY BEFORE RETURNING TO NORMAL DUTY. IT WAS REPORTED THE PATIENT WAS NOT INJURED AND WAS UNAWARE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437433 93H PROFLEXX H FRAME COT 93H PROFLEXX H FRAME COT FPO FERNO-WASHINGTON, INC. 0015762

    Patients

    Seq Age Sex Outcome Treatment
    1