BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3970423 · Received July 31, 2014

    Report

    Report Number
    3008262382-2014-00433
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE (B)(4) POWER CHAIR QUICK RELEASE PIN THAT HOLDS THE FOOTBOARD TO THE CHAIR CONTINUES TO FALL OUT OF THE PRONTO M61 EVERYTIME THE CONSUMER GOES OVER A BUMP ON THE SIDEWALK. CHAIR IS ALSO VIBRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447895 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M61PSR18B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other