BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERLANDER- PEV2000

    MDR report key: 351932 · Received September 6, 2001

    Report

    Report Number
    1931307-2001-00001
    Event Type
    Malfunction
    Date Received
    September 6, 2001
    Date of Event
    July 24, 2000
    Report Date
    August 29, 2001
    Manufacturer
    RAYE'S, INC., DBA, WHEELCHAIRS OF KANSAS
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED CALL THAT A PEV (POWERCHAIR) HAD BEEN ALLEGEDLY AFFECTED BY EMI (ELECTROMAGNETIC INTERFERENCE) AND POSSIBLY INJURED A CONSUMER. CONSUMER HAD GOTTEN OUT OF CHAIR, THE CHAIR LURCHED FORWARD AND KNOCKED THE CONSUMER TO GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40712 OVERLANDER- PEV2000 POWERED WHEELCHAIR ITI RAYE'S, INC., DBA, WHEELCHAIRS OF KANSAS OVERLANDER/PEV2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability