BEUDAMED
    FDA Adverse Event Injury Summary report: N

    40 OS CHAIR

    MDR report key: 5106118 · Received September 25, 2015

    Report

    Report Number
    1523574-2015-00083
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    September 14, 2015
    Report Date
    November 5, 2015
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE CONDITION OF THE UNIT INDICATES IT HAS HAD EXTENSIVE USE FOR ITS AGE. THE LOCKING MECHANISM WAS FUNCTIONAL AND NO MALFUNCTIONS WERE DETECTED THROUGHOUT THE EVALUATION. IT COULD NOT BE DETERMINED HOW THE LOCK BAR WAS BENT; HOWEVER, IT WAS CONFIRMED THE BEND TO THE LOCK BAR DOES NOT IMPAIR THE FUNCTION OF THE LOCK BAR. THE CUSTOMER WAS ASKED IF THEY HAD RECEIVED ANY FEEDBACK FROM THE HOSPITAL OR THE PATIENT REGARDING SERIOUS INJURY RELATED TO THE INCIDENT AND THEY STATED THEY HAD RECEIVED NO SUCH COMMUNICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE MOVING A PATIENT ACROSS A DOORWAY SADDLE, THE STAIR CHAIR ALLEGEDLY GAVE WAY AND THE EMT LOST THEIR FOOTING ALLOWING THE CHAIR AND PATIENT TO FALL BACKWARDS. THE PATIENT ALLEGEDLY HIT HER HEAD ON THE O2 BAG AND LATER COMPLAINED OF SOME HEAD PAIN. THE CUSTOMER REPORTED THE ONLY NOTICABLE DAMAGE TO THE CHAIR WAS A BENT RELEASE BAR; HOWEVER, THE CHAIR IS BEING RETURNED TO FERNO FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE MOVING A PATIENT ACROSS A DOORWAY SADDLE, THE STAIR CHAIR ALLEGEDLY GAVE WAY AND THE EMT LOST THEIR FOOTING ALLOWING THE CHAIR AND PATIENT TO FALL BACKWARDS. THE PATIENT ALLEGEDLY HIT HER HEAD ON THE O2 BAG AND LATER COMPLAINED OF SOME HEAD PAIN. THE CUSTOMER REPORTED THE ONLY NOTICABLE DAMAGE TO THE CHAIR WAS A BENT RELEASE BAR; HOWEVER, THE CHAIR IS BEING RETURNED TO FERNO FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635266 40 OS CHAIR 40 OS CHAIR FPP FERNO-WASHINGTON, INC. 0714851

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other