BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 19435652 · Received May 31, 2024

    Report

    Report Number
    3008370857-2024-00009
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    May 8, 2024
    Report Date
    May 31, 2024
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTS PROVIDED TO PERMOBIL CLAIM THE END-USER HAVING ROTATED THE SPEED CONTROL DIAL BACK TO DISENGAGE THE DRIVE MOTOR, BUT THE WHEELCHAIR CONTINUED TO MOVE FORWARD AND STRUCK A CURB FORCING THE END-USER TO FALL OUT OF SEATING TO THE GROUND. INITIAL REPORT INDICATED THE END-USER HAVING SUSTAINED A FRACTURED HIP AS A RESULT OF THE FALL. THE INFORMATION RECEIVED WAS REPORTED TO HAVE BEEN PROVIDED TO THE DEALERSHIP BY AN ATTENDING THERAPIST. AT TIME OF THIS REPORT, NEITHER THE DEALERSHIP NOR PERMOBIL HAVE BEEN ABLE TO ESTABLISH CONTACT WITH THE END-USER IN EFFORT TO INSPECT THE DEVICE, OR TO CONFIRM THE SEQUENCE OF EVENTS AS INITIALLY REPORTED. AT THIS TIME, PERMOBIL IS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT WITHOUT SPECULATION. PERMOBIL WILL CONTINUE TO INVESTIGATE, AND IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING AS THE END-USER WAS UNDER POWER WITH THE SMARTDRIVE MX2+ POWER ASSIST DEVICE, THEY REPORTEDLY ROTATED THE SPEED CONTROL DIAL BACK TO DISENGAGE THE DRIVE MOTOR, BUT REPORTS THE DEVICE CONTINUED TO MOVE WHICH REPORTEDLY FORCED THE WHEELCHAIR TO IMPACT INTO A CURB. THIS ACTION REPORTEDLY CAUSED THE END-USER TO LOSE POSITIONING IN THE WHEELCHAIR AND FALL OUT OF SEATING, TO THE GROUND, WHERE THEY REPORTEDLY SUSTAINED INJURIES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312037 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A

    Patients

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