BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL F3 CORPUS

    MDR report key: 18707495 · Received February 14, 2024

    Report

    Report Number
    1221084-2024-00001
    Event Type
    Death
    Date Received
    February 14, 2024
    Date of Event
    January 15, 2024
    Report Date
    February 14, 2024
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818676433
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL RECEIVED CORRESPONDENCE FROM THE SERVICE PROVIDER, VIA THE END-USERS FAMILY, DESCRIBING AN INCIDENT HAVING OCCURRED WERE WHILE THE END-USER WAS IN PROCESS OF POSITIONING THEIR F3 POWERCHAIR ON TO A PLATFORM LIFT DESIGNED TO TRANSPORT A WHEELCHAIR UP AND DOWN A FLIGHT OF STAIRS. WITNESSES INDICATE DURING THE PROCESS OF ATTEMPTING TO CENTER THE WHEELCHAIR UPON THE PLATFORM, THE END-USER INADVERTENTLY ENGAGED A FORWARD DRIVE COMMAND ON THE JOYSTICK WHICH PROPELLED THE DEVICE OFF THE END OF THE PLATFORM RESULTING IN THE WHEELCHAIR, WITH THE END-USER, FALLING FROM THE ELEVATED HEIGHT AND DOWN THE FIGHT OF STAIRS. THE END-USERS FAMILY WAS NOT FORTHCOMING AS TO THE EXTENT OF INJURIES, ONLY REPORTING THE END-USER HAVING RECEIVED SIGNIFANT INJURIES THAT EVENTUALLY RESULTED IN THEIR DEATH. NO CLAIMS OR ALLEGATIONS WERE MADE FROM WITNESSES OR FAMILY MEMBERS, TO THE SERVICE PROVIDER OR TO PERMOBIL, OF ANY PRODUCT MALFUNCTION HAVING OCCURRED TO HAVE CONTRIBUTED TO THIS UNFORTUNATE EVENT. ALL REPORTS FROM WITNESSES INDICATE THIS EVENT WAS CAUSED BY THE INADVERTENT USER ERROR IN INTENTIONAL ENGAGEMENT OF A DRIVE COMMAND FROM AN ELEVATED SURFACE. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PROR TO DISTRIBUTION.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING WHILE THE END-USER WAS ATTEMPTING TO POSITION THE F3 CORPUS DEVICE ON PLATFORM LIFT, THE END-USER INADVERTENTLY DROVE FORWARD, OFF THE PLATFORM, AND DOWN A FLIGHT OF STAIRS. REPORT INDICATES THE FALL RESULTED WITH THE END-USER SUCCUMBING TO THEIR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798034 PERMOBIL F3 CORPUS POWERED WHEELCHAIR ITI PERMOBIL INC. F3 CORPUS N/A 17330818676433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Death