BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 18670894 · Received February 8, 2024

    Report

    Report Number
    3008370857-2024-00005
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    October 15, 2023
    Report Date
    February 8, 2024
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT RECEIVED CLAIMS WHILE THE END-USER WAS OPERATING THE SMARTDRIVE DEVICE VIA A SPEED CONTROL DIAL IN A SCHOOL SETTING, THE END-USER CRASHED INTO A BENCH AND CONTINUED TO DRIVE THROUGH WITHOUT TURNING OFF THE SMARTDRIVE DEVICE. REPORT CLAIMS THE W/C EVENTUALLY FELL TO THE SIDE AND THE END-USER REPORTEDLY BANGED THEIR HEAD ON THE FLOOR. THE END-USER REPORTED HAVING BOUTS OF DIZZINESS FOR APPROXIMATELY 1.5 WEEKS AFTER THE EVENT BUT WERE NEVER FORMALLY DIAGNOSED WITH AN INJURY. THE DEVICE WAS FOUND TO REMAIN FULLY OPERATIONAL, WITH NO NOTABLE DEFECTS OR SIGNS OF A MALFUNCTION HAVING OCCURRED. FURTHER REPORTS INDICATE THE END-USER FAILED TO ROTATE THE DIAL BACK TO SLOW THEIR SPEED AND FAILED TO DEPRESS THE DIAL TO TURN OFF THE DRIVE MOTOR AFTER CONTACTING A BENCH. THE SCHOOL STAFF THAT WERE ACCOMPANYING THE END-USER HAD NO TRAINING ON HOW THE SPEED CONTROL DIAL OPERATED, THUS THEY WERE UNABLE TO ASSIST DURING THE EVENT. A PERMOBIL REPRESENTATIVE HAS CONDUCTED FURTHER TRAINING WITH THE END-USER, FAMILY MEMBERS, AND SCHOOL STAFF ON THE PROPER USE AND FEATURES OF THE SPEED CONTROL DIAL. NO CLAIMS OR ALLEGATIONS WERE MADE OF A PRODUCT MALFUNCTION HAVING OCCURRED, WITH ALL REPORTS INDICATING AN INADVERTENT USE ERROR. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING DURING AN EVALUATION OF SMARTDRIVE USE, THE END-USER REPORTEDLY CONTINUED TO DRIVE, WITHOUT DISENGAGING THE DRIVE MOTOR, FORCING USER TO CRASH INTO A BENCH AND EVENTUALLY FORCING THE W/C TO FALL ON TO ITS SIDE. END-USER REPORTEDLY SUSTAINED INJURIES REQUIRING A MEDICAL EVALUATION TO ASSESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791215 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

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