BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 21020970 · Received December 26, 2024

    Report

    Report Number
    3008370857-2024-00018
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    December 1, 2023
    Report Date
    December 26, 2024
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTS CLAIM THE END-USER'S WHEELCHAIR WAS STRUCK BY THE MOTOR VEHICLE HARD ENOUGH TO KNOCK THE WHEELCHAIR ON TO ITS SIDE WHERE THE END-USER REPORTEDLY SUSTAINED A CONCUSSION AND CUTS TO THEIR LEGS REQUIRING WOUND THERAPY. REPORT CLAIMS THE EVENT OCCURRED APPROXIMATELY 1 YEAR PRIOR, AND THE INCIDENT WAS NOT REPORTED TO THE SERVICE PROVIDER NOR PERMOBIL. AS THIS REPORTED EVENT OCCURRED APPROXIMATELY 1 YEAR PRIOR, PERMOBIL IS UNABLE TO CONFIRM THE FAILURE AS REPORTED. DUE TO AN INCREASE IN REPORTS OF SIMILAR FAILURES, A CAPA INVESTIGATION, 24-015, WAS IMPLEMENTED. INVESTIGATION FOUND AN UNDESIRABLE INTERACTION BETWEEN THE CIRCUIT DESIGN AND THE NEW POTENTIOMETER OVER TIME. FURTHER ENGINEERING ANALYSIS CONCLUDED THAT THE NEW POTENTIOMETER'S INTERNAL CONTACT RESISTANCE WAS CHANGING DURING USE, AND THE CIRCUIT WAS OVERLY SENSITIVE TO THIS CHANGE. THE INVESTIGATION ALSO SHOWED THAT THE INTERNAL CONTACT RESISTANCE OF THE PREVIOUS POTENTIOMETERS, USED PRIOR TO (B)(6) 2023, DID NOT CHANGE MUCH OVER TIME WHEN COMPARED TO THE NEW POTENTIOMETER, CONCLUDING THE ROOT-CAUSE FOR THE FAILURE WAS WITHIN THE NEW POTENTIOMETER. AS PART OF THE CAPA, PERMOBIL HAS IMPLEMENTED A MARKET CORRECTION, 3008370857-12/19/2024-001-C, TO ADDRESS POTENTIALLY AFFECTED COMPONENTS MANUFACTURED BETWEEN AUGUST 17, 2023 THROUGH NOVEMBER 21, 2024.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING WHILE THE END-USER WAS USING THE SMARTDRIVE MX2+ DEVICE VIA A SPEED CONTROL DIAL, CLAIMS THE SMARTDRIVE UNIT CONTINUED TO DRIVE AFTER ROTATING THE DIAL TO THE NEUTRAL/DISENGAGED POSITION. THIS REPORTEDLY ALLOWED THE END-USER TO BE STRUCK BY A MOTOR VEHICLE WHERE THE END-USER WAS THROWN FROM THEIR WHEELCHAIR TO THE GROUND. REPORTS INDICATE THE END-USER SUSTAINED INJURIES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890413 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

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