BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 22045599 · Received May 19, 2025

    Report

    Report Number
    3008370857-2025-00129
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 25, 2025
    Report Date
    June 9, 2025
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT SPEED CONTROL DIAL WAS RETURNED TO PERMOBIL, EVALUATED, AND WAS FOUND TO REMAIN FULLY OPERATIONAL WITH NO SIGNS OF A MALFUNCTION HAVING OCCURRED. THROUGH TESTING PERMOBIL WAS UNABLE TO REPLICATE THE FAILURE OF INVOLUNTARY MOVEMENT, FINDING THE COMPONENT TO OPERATE NORMALLY AS PER DESIGN SPECIFICATIONS. PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE FOR THE ALLEGED COMPLAINT WITHOUT SPECULATION.

    Additional Manufacturer Narrative · 0

    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 AUGUST 17, 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, Z-1116-2025, TO ADDRESS POTENTIALLY AFFECTED COMPONENTS MANUFACTURED BETWEEN AUGUST 17, 2023 THROUGH NOVEMBER 21, 2024. THIS REPORT IS CLAIMED AS BEING THE NEW DESIGN OF SPEED CONTROL DIAL THAT THE END-USER RECEIVED AS PART OF THE MARKET CORRECTION. AT TIME OF THIS SUBMISSION, PERMOBIL HAS YET TO RECEIVE THE SUSPECT COMPONENT FOR INSPECTION, THUS CANNOT CONFIRM THE PRODUCT ALLEGED AS HAVING FAILED TO BE THE NEW DESIGN, NOR CONFIRM A FAILURE HAVING OCCURRED AS ALLEGED. IF PERMOBIL RECEIVES ANY NEW INFORMATION, 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 WHILE THE END-USER WAS USING THE SMARTDRIVE MX2+ DEVICE VIA A SPEED CONTROL DIAL, CLAIMS WHILE DIAL IS IN A STAND-BY/NEUTRAL POSITION, ON OCCASION THE DIAL WILL ENGAGE A DRIVE COMMAND WITHOUT PHYSICAL MANIPULATION. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144932 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown