BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRACKET, SUPPORT ARM

    MDR report key: 3870804 · Received June 12, 2014

    Report

    Report Number
    2031642-2014-00490
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 16, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BRACKET, SUPPORT ARM.

    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 FELL OFF THE DEVICE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT OR USER HARM. THE CUSTOMER REPORTED THE RESPIRATORY THERAPIST (RT) WAS SETTING THE VENTILATOR UP FOR PATIENT USE AND REPORTED THE BRACKET CAME OFF THE RAIL. THE RT WAS BETWEEN THE VENTILATOR AND THE PATIENT AND GRABBED THE BRACKET AND ARM AS IT CAME OFF. THE CUSTOMER REPORTED THAT THE BRACKET LOOSENS AFTER TIGHTENING. THE SCREW THAT SECURES THE BRACKET TO THE RAIL MUST BE FULLY ENGAGED WHEN MOUNTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347314 BRACKET, SUPPORT ARM BRACKET, SUPPORT ARM MNT RESPIRONICS CALIFORNIA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 V60 VENTILATOR