BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3771689 · Received April 24, 2014

    Report

    Report Number
    3004493922-2014-00572
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATES THAT THE ARM ON HER RIGHT SIDE WHERE THE JOYSTICK IS LOCATED IS LOOSE AND SQUEAKY. END USER STATED SHE IS NOT AWARE OF WHAT MAY HAVE CAUSED THE ARM TO BE LOOSE. END USER STATED NO INJURIES PERTAINING TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250104 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 92 Other