BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4220214 · Received November 3, 2014

    Report

    Report Number
    1525712-2014-07526
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 14, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER STATES THAT THE CHAIR GOES SLOW AND THEN FAST. HE IS NOT THE ORIGINAL OWNER. HE PURCHASED THE CHAIR FROM ANOTHER INDIVIDUAL. HE STATES THAT THE CHAIR SAT FOR ABOUT A YEAR WITHOUT BEING USED. HE HAS NOT REPLACED THE BATTERIES. CONSUMER DIDN'T HAVE THE SERIAL NUMBER ON THE CHAIR, SO WILL CALL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701663 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other