BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 20237777 · Received September 17, 2024

    Report

    Report Number
    3008370857-2024-00011
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 17, 2024
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE END-USER STATED WHEN ATTEMPTING TO STOP THE SMARTDRIVE DEVICE WITH THE APPLE WATCH VIA A TAPPING MOTION, CLAIMS THE DEVICE CONTINUED TO RUN FORCING THEM TO MANEUVER INTO WALL. THE END-USER STATED THEY RE-INJURED THEIR LEFT HAND/WRIST, FROM A PREVIOUS SURGERY, WITH LOCALIZED SWELLING AND GENERAL SORENESS, BUT DID NOT SEEK ANY MEDICAL INTERVENTION. THE END-USER STATED THE THEY WERE ABLE TO STOP THE DEVICE AFTERWARDS BY GIVING ANOTHER SET OF TAPPING MOTIONS, ONLY MENTIONING THAT THE INITIAL TAPPING DID NOT STOP THE MOTOR. THE END-USER STATED THIS ANOMALY HAD OCCURRED BEFORE, BUT THEY WERE ABLE TO STOP IT VIA A SECOND SET OF TAPPING GESTURES. REPORTS INDICATED THE DEVICE DID RESPOND WITH A SECOND SET OF GESTURES INDICATING THE MX2+ APPLICATION AND SMARTDRIVE DEVICE WERE WORKING AS PER DESIGN. AS THE APPLE WATCH WAS PRIVATELY PURCHASED AND PERMOBIL DOES NOT HAVE ANY KNOWLEDGE AS TO INTERNAL WORKINGS OF THE WATCH, PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE OF THIS REPORTED EVENT WITHOUT SPECULATION. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    REPORTS WHILE OPERATING THE SMARTDRIVE MX2+ IN THE END-USERS HOME, CLAIMS WHEN GIVEN A DOUBLE TAP MOTION ON THEIR APPLE WATCH TO STOP, THE DEVICE REPORTEDLY CONTINUED TO RUN FORCING THE END-USER TO COLLIDE THEIR WHEELCHAIR INTO A WALL. NO SERIOUS INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808686 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown