BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL CHAIRMAN ENTRA

    MDR report key: 6149762 · Received December 6, 2016

    Report

    Report Number
    1221084-2016-00051
    Event Type
    Death
    Date Received
    December 6, 2016
    Report Date
    January 4, 2017
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K960951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS INSPECTED JOINTLY BY PERMOBIL (B)(4), AND NO ISSUES WERE NOTED THAT INDICATE THE CHAIR TO HAVING MALFUNCTIONED WHICH WOULD HAVE LED TO THE EVENT. REPORTS RECEIVED WERE THE UNIT WAS FOUND FULLY OPERATIONAL WITH NO RECORDED FAULTS IN THE SYSTEM LOG INDICATING A SYSTEM MALFUNCTION THAT COULD HAVE ATTRIBUTED TO THE REPORTED EVENT. THE ACTUAL ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED, BUT IT IS SPECULATED THAT IT WAS EITHER USER OR ATTENDANT DRIVE ERRORS THAT LED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PERMOBIL RECEIVED REPORT FROM (B)(6) POLICE - (B)(6) THAT THEY WERE INVESTIGATING AN INCIDENT RESULTING IN AN INDIVIDUAL'S DEATH. REPORTS GIVEN WERE AN INDIVIDUAL WAS BEING LOADED INTO A VEHICLE WHILE OCCUPYING A PERMOBIL WHEELCHAIR. AS CLIENT WAS BEING MANEUVERED FROM THE LIFT PLATFORM INTO THE VEHICLE, THE WHEELCHAIR ALLEGEDLY DROVE IN THE OPPOSITE DIRECTION AS INTENDED, OFF OF THE END OF THE PLATFORM LIFT, RESULTING IN THE END-USERS DEATH. IT WAS NOT REPORTED WHEN THE ACTUAL DATE THIS EVENT OCCURRED OR WHEN THEREAFTER THE END-USER DECEASED. IT IS UNCLEAR AT THIS TIME IF THE CHAIR MALFUNCTIONED, OR IF THIS EVENT IS ATTRIBUTED TO USER/ATTENDANT ERROR. AN INSPECTION OF THE CHAIR HAS NOT BEEN PERFORMED AT THIS TIME DUE TO THE ONGOING POLICE INVESTIGATION. AN INSPECTION DATE HAS BEEN SCHEDULED FOR A (B)(4) INVESTIGATION FIRM, ALONG WITH PERMOBIL, TO INSPECT THE CHAIR FOR ANY IRREGULARITIES. UPON THE COMPLETION OF THE INSPECTION AND INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT DRIVER ATTENDANT WAS PRELOADING THE WHEELCHAIR ON A VEHICLE LIFT WHILE THE END-USER WAS OCCUPYING THE WHEELCHAIR. IN AN ATTEMPT TO MANEUVER THE WHEELCHAIR INTO THE VEHICLE, THE DEVICE ALLEGEDLY DROVE BACKWARDS OVER THE EDGE OF THE VEHICLE LIFT. REPORTS ARE CLIENT SUBSEQUENTLY DIED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799941 PERMOBIL CHAIRMAN ENTRA POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) CHAIRMAN ENTRA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death