BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRACKET, SUPPORT ARM

    MDR report key: 3819467 · Received May 19, 2014

    Report

    Report Number
    2031642-2014-00351
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 6, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BRACKET, SUPPORT ARM.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER WAS ADVISED TO TIGHTEN THE THUMBSCREW THAT SECURES THE BRACKET TO THE SIDE RAIL OF THE CART TO PREVENT THE MOVEMENT OF THE BRACKET. THERE WERE NO PARTS REPLACED DURING SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SUPPORT ARM BRACKET MOUNTED ON A VENTILATOR STAND CAME OFF THE RAIL IT WAS MOUNTED ON AND THE USER GOT STRUCK IN FACE WITH THE SUPPORT ARM. THE CUSTOMER REPORTED THE RESPIRATORY CARE PRACTITIONER (RCP) USER WAS REMOVING THE HEATED WIRE CABLES FROM THE VENTILATOR POST PATIENT USE WHEN THE SUPPORT ARM FELL OFF AND HIT THE RCP IN THE FACE. THE CUSTOMER REPORTED THE USER NEEDED ICE PLACED ON THE SWOLLEN AREA AND THE USER IS FINE. THE SCREW THAT SECURES THE BRACKET TO THE RAIL MUST BE FULLY ENGAGED WHEN MOUNTED TO PREVENT IT FROM MOVING OFF THE RAIL DURING MOVEMENT OF THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296748 BRACKET, SUPPORT ARM BRACKET, SUPPORT ARM MNT RESPIRONICS CALIFORNIA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other V60 VENTILATOR