BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 12017790 · Received June 17, 2021

    Report

    Report Number
    3014522447-2021-00003
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 22, 2021
    Report Date
    June 17, 2021
    Manufacturer
    MOBIUS MOBILIYT LLC.
    Product Code
    IMK
    UDI-DI
    00857584008003
    PMA / PMN Number
    K172601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOBIUS MOBILITY INVESTIGATION: WHEN THE USER INITIALLY SENT THE EMAIL LOOKING FOR REPLACEMENT PARTS, SHE DID NOT INFORM US OF ANY INJURIES. MOBIUS MOBILITY WAS NOT INFORMED OF THE NEED FOR MEDICAL ATTENTION UNTIL (B)(6) 2021 WHEN DIRECT CONTACT WAS MADE WITH THE CUSTOMER. THE USER INDICATED "BEING A PARA, I WATCHED IT FOR A DAY OR TWO BEFORE GOING TO THE URGENT CARE CLINIC IN FORT WORTH." IN REVIEW OF THE ACCIDENT, IT IS BELIEVED THAT WET MUDDY CONDITIONS ON THE WHEELCHAIR LIFT INSTALLED ON THE USER'S TRUCK RESULTED IN THE IBOT® SLIDING OFF THE LIFT DUE TO THE ANGLE OF THE TRUCK. THE USER STATED: "I WAS ON THE LIFT OF THE TRUCK AND IT WAS RAINING. THE LIFT WAS WET AND THE CHAIR SLID OFF OF IT". THE USER WAS NOT MANEUVERING THE IBOT® AT THE TIME THE CHAIR STARTED TO SLIDE. MOBIUS WAS NOT INFORMED OF THE TYPE OR MODEL OF LIFT, BUT THE USER STATED ". IT'S NOT THE IBOT'S FAULT. I KNOW THIS LIFT ISN'T APPROVED FOR OCCUPIED USE. IT'S A REGULAR MODIFIED PICKUP TRUCK WITH A LIFT ON IT THAT GETS ME IN AND OUT OF THE DRIVER SIDE". FROM THE INVESTIGATION AND THE USER ACCOUNT OF THE ACCIDENT, IT WAS THE RESULT OF A WET SLIPPERY SURFACE. THE IBOT USER MANUAL INDICATES: "DRIVING ON CERTAIN SURFACES MAY CAUSE THE DEVICE TO TIP OVER. TO AVOID THIS FROM HAPPENING, BE AWARE OF THE SURFACES TO AVOID WET, ICY OR SLIPPERY SURFACES."

    Description of Event or Problem · 1

    CUSTOMER CONTACTED MOBIUS MOBILITY ON (B)(6) 2021 AND INFORMED US OF AN EVENT INVOLVING HER TRUCK LIFT THAT CAUSED SOME DAMAGE TO HER IBOT® AND NEEDED SOME PARTS. ON (B)(6) 2021 THE USER INFORMED US SHE WAS IN THE IBOT WHEN THE EVENT OCCURRED ON (B)(6) 2021 AND THAT SHE BROKE HER LEFT FOOT IN A FALL FROM THE WHEELCHAIR LIFT. THE IBOT® WAS NOT BEING MANEUVERED BY THE USER AT THE TIME OF THE EVENT, HOWEVER A WET MUDDY SURFACE ON THE LIFT RESULTED IN THE IBOT SLIDING OFF THE LIFT. THIS RESULTED IN THE FALL AND THE INJURY REQUIRING MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910907 IBOT PMD IBOT IMK MOBIUS MOBILIYT LLC. IBOT PMD N/A 00857584008003

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention