BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL

    MDR report key: 3875142 · Received May 8, 2014

    Report

    Report Number
    1221084-2014-00010
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 7, 2014
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL REP (B)(4) HAS BEEN TO THE SISTER'S HOME TO SEE THE RAMP. THE RAMP IS 8FT LONG AND IS GOING UP STEPS WHICH RISE 22INCHES. THE ADA SPECIFICATION FOR THIS RAMP WOULD BE 1:12 OR 22 FEET. THE RECOMMENDATIONS I SEE IN THE INDUSTRY FOR AN OCCUPIED CHAIR ON A RESIDENTIAL RAMP IS 2:12 WHICH WOULD BE 11 FEET AND FOR AN UNOCCUPIED CHAIR IS 3:12 OR 8 FEET. THE ANGLE THAT THE RAMP CURRENTLY IS AT, IS 13 DEGREES. THE PERMOBIL MANUAL CLEARLY STATES THAT 10 DEGREES IS THE MAXIMUM SAFE ANGLE. THE CHAIR LEFT PERMOBIL IN COMPLIANCE WITH THE DMR THE CHAIR "TIPPED" BECAUSE OF DRIVER ERROR THE SLOPE OF THE RAMP IS BEYOND THE SPECIFICATION FOR THE CHAIR.

    Description of Event or Problem · 1

    CLIENT REPORTS THAT HE WAS GOING DOWN A TEMPORARY PORTABLE RAMP AT HIS SISTER'S HOUSE WHEN HIS CHAIR TIPPED FORWARD. HE RECEIVED A BROKEN LEG IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278056 PERMOBIL POWER WHEELCHAIR ITI PERMOBIL, INC. C300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other