BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 22829478 · Received August 18, 2025

    Report

    Report Number
    3008370857-2025-00192
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    September 4, 2024
    Report Date
    August 18, 2025
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL WAS MADE AWARE OF THE EVENT AFTER HAVING RECEIVED CORRESPONDENCE FROM LEGAL COUNSEL REPRESENTING THE END-USER WHERE INITIAL CORRESPONDENCE DESCRIBED THE ALLEGED ISSUE AS BEING AN ACT OF INVOLUNTARY ACTIVATION OF THE SPEED CONTROL DIAL WHICH REPORTEDLY RESULTED WITH THE END-USER TO LOSE UPRIGHT POSITIONING AND FALL TO THE GROUND WHERE THEY SUSTAINED INJURIES. IT WAS CLAIMED THE END-USER HAVING SUSTAINED UNDESCRIPTIVE INJURIES TO ONE OF THEIR APPENDAGES THAT REQUIRED STAPLES TO CLOSE THE WOUND. THIS EVENT REPORTEDLY OCCURRED IN SEPTEMBER 2024, WITH NO RECORD OF PERMOBIL HAVING BEEN NOTIFIED AT THAT TIME. 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. REVIEW OF CLIENT FILE INDICATES THIS DEVICE AS POTENTIALLY HAVING THE ORIGINAL SPEED CONTROL DIAL WITH NO RECORD OF THE REVISED VERSION BEING SHIPPED. 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

    PERMOBIL RECEIVED REPORT CLAIMING WHILE THE END-USER WAS OPERATING THEIR MANUAL WHEELCHAIR WITH AN MX2+ SMARTDRIVE UNIT, AT ONE POINT THE DEVICE REPORTEDLY ENGAGED A DRIVE COMMAND WITHOUT ANY PHYSICAL MANIPULATION BY THE END-USER. REPORT CLAIMS THE END-USER WAS EJECTED FROM THE WHEELCHAIR WHERE THEY SUSTAINED INJURIES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043811 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization