BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL

    MDR report key: 3802837 · Received May 2, 2014

    Report

    Report Number
    1221084-2014-00008
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 2, 2014
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLIENT REPORTS THAT HE STOOD UP IN THE SEATING TO DO A TRANSFER. THE CLIENT REPORTS THAT HE TURNED OFF HIS POWER AND STOPPED OFF THE FOOTPLATE. DURING THIS PROCESS, HIS FOOT GOT CAUGHT UNDER THE FOOTPLATE AND WHEN HE WENT TO TAKE A STEP, HIS FOOT GOT TRAPPED AND HE FELL. THE RESULTING FALL CAUSED THE CLIENT TO BREAK HIS FEMUR AND KNEE WHICH RESULTED IN A HOSPITAL STAY. THE DEVICE ITSELF DID NOT SUFFER ANY MALFUNCTION, THE ROOT CAUSE DETERMINED FOR THIS ISSUE WAS USER ERROR. THE CLIENT REQUESTED THAT THE FOOTPLATES BE PLACED IN AN UNLOCKED POSITION. THE CURRENT DESIGN OF THE FOOTPLATES INCLUDES A LOCKING BOLT WHICH PREVENTS THE FOOTPLATES FROM MOVING FOR SAFETY PURPOSES. THE CLIENT WAS INFORMED THAT THE DEALER WHO SUPPLIED THE CLIENT'S CHAIR HAS THE CAPABILITY TO REMOVE THESE LOCKING BOLTS TO ALLOW THE FOOTPLATES TO BE MOVED INTO THE UPRIGHT POSITION. THE DEALER WAS CONTACTED ON (B)(4) 2014, AND IS IN THE PROCESS OF SCHEDULING THIS MODIFICATION WITH THE CLIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263998 PERMOBIL POWER WHEELCHAIR ITI PERMOBIL, INC. C500 VS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization