BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3800041 · Received May 8, 2014

    Report

    Report Number
    3004493922-2014-00666
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    March 31, 2014
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    BATTERIES ARE DEPLETING FASTER THAN NORMAL ON A M51PSEMIBLUE POWER WHEEL CHAIR. WITHIN A MILE OF DRIVING THE BATTERIES DIED AND END USERS HUSBAND HAD TO PUSH HER HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279433 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51PSEMIBLUE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 Other