BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 7940853 · Received October 5, 2018

    Report

    Report Number
    3008370857-2018-00003
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MAX MOBILITY, LLC
    Product Code
    ITI
    UDI-DI
    00861896000303
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE MANUFACTURING RECORDS SHOWED THE SPECIFIC DEVICE AND ALL ITS PARTS WERE MANUFACTURED TO SPECIFICATION, PASSED ALL QUALITY CHECKS, AND WERE RELEASED AFTER FINAL TESTING OF THE DEVICE WAS PERFORMED. THE SPECIFIC DEVICE WAS MANUFACTURED / RELEASED ON 7/7/2017. THERE ARE NO PAST SERVICE / COMPLAINT RECORDS FOR THE PARTICULAR DEVICE AND IT HAD NOT BEEN RETURNED OR BROUGHT IN FOR SERVICE AT ANY TIME IN THE PAST. SO THE DATE OF 9/13/18 AS THE FIRST OF MAX MOBILITY BECAME AWARE HOLDS TRUE AND THE HANDLING OF EVERYTHING ACCORDING TO THE ESTABLISHED QUALITY SYSTEM PROCEDURES WAS VERIFIED. FROM THE INFORMATION PROVIDED AND COLLECTED IT HAS BEEN CONCLUDED THAT THE OCCURRENCE / EVENT CAN BE ATTRIBUTED TO THE USER'S INABILITY / ERROR TO SUFFICIENTLY PERFORM THE NECESSARY ACTIONS TO SAFELY AND SUCCESSFULLY OPERATE THE DEVICE AND HIS WHEELCHAIR IN THE USE ENVIRONMENT. THIS INCLUDES THE USER'S ERROR / FAILURE TO DEACTIVATE THE DRIVING AND POTENTIALLY TURN POWER ASSIST / SD OFF PRIOR TO DOING DOWN DECLINES AS WARNED / RECOMMENDED IN THE INSTRUCTIONS FOR USE. ENGINEERING ALSO REVIEWED AND NOTED THAT THE USER, BECAUSE OPERATING THE DEVICE AT "A HIGH RATE OF SPEED" INSTEAD OF A SLOW MANAGEABLE SPEED NECESSARY FOR THE SPECIFIC ENVIRONMENT, COULD HAVE SUCCESSFULLY DEACTIVATED THE MOTOR BUT IT WAS MOMENTUM AND FAILURE OF THE USER TO SUCCESSFULLY BRAKE / SLOW DOWN / STOP THE WHEELCHAIR VIA THE HANDRIMS THAT CAUSED THE EVENT. FOR THIS TYPE OF FAILURE (FAILURE TO FOLLOW INSTRUCTIONS, USE ERROR CAUSED OR CONTRIBUTED TO EVENT) WITH THIS MODEL (MX2+ - PAST MODELS DISREGARDED AS DIFFERENT OPERATION / FEATURES), THE DEVICE DESIGN AND THE CONTROL MEASURES TO PREVENT THIS TYPE OF OCCURRENCE WERE ALSO REVIEWED FOR THEIR ACCEPTABILITY - WHICH WAS VERIFIED. THESE CONTROL MEASURES INCLUDE INSTRUCTIONS FOR USE (CAUTION FOR INTENDED CONDITIONS FOR USE AND RECOMMENDED ACTIONS / OPERATION FOR CERTAIN ENVIRONMENTS, INSTRUCTION FOR WHEN TO TURN POWER ASSIST OFF, DEACTIVATION / ACTIVATION INSTRUCTION), ACTIVATION AND DEACTIVATION CRITERIA, "TAP" SENSITIVITY, AMONG OTHERS. IT CAN BE NOTED THAT ALL MODELS OF THE DEVICE EMPLOY REDUNDANT DESIGNS FOR DEACTIVATION, SO THAT IF ONE MEANS WERE TO FAIL (WHICH CAN BE CONSIDERED TO BE "IMPROBABLE") REGARDLESS OF REASON (I.E. USER NOT SUFFICIENTLY PERFORMING THE ACTION NECESSARY) THERE IS ALWAYS A SECOND MEANS (I.E. TURNING POWER ASSIST OFF). IN CONCLUSION, NO IMMEDIATE CORRECTIVE ACTION IS NEEDED, AS THE DEVICE IS DESIGNED TO REDUCE THE AMOUNT OF RISK OF THIS TYPE AS FAR AS POSSIBLE, THE DESIGN IS SAFE, THE UNIT WAS MANUFACTURED TO SPECIFICATION, SUFFICIENT INSTRUCTION IS GIVEN, AND IT FUNCTIONED AS EXPECTED. THIS OCCURRENCE, COMPLAINT AND INVESTIGATION WILL BE AGAIN REVIEWED FOR ADDITIONAL OCCURRENCES / TRENDS AS PART OF OTHER QUALITY SYSTEM PROCEDURES WHICH MIGHT WARRANT FUTURE CORRECTIVE ACTION AND / OR UPDATING OF RISK MANAGEMENT ACTIVITIES.

    Description of Event or Problem · 1

    AS DESCRIBED TO THE TECHNICAL SUPPORT REPRESENTATIVE BY THE USER, USER WAS OPERATING SMARTDRIVE MODEL MX2+ AND, AFTER FAILING TO [1] RECOGNIZE THAT NO POWER ASSIST FROM THE DEVICE IS NEEDED WHEN GOING DOWN A DECLINE (TO WHICH IT SHOULD BE DEACTIVATED / TURNED OFF AS INSTRUCTED IN THE DEVICE LABELING), [2] MAINTAIN A SLOW SPEED WHEN GOING DOWN A TWO-TIERED RAMP REQUIRING A TURN AND [3] SUCCESSFULLY DEACTIVATE THE POWER ASSIST DRIVING / STOP THE WHEELCHAIR / NAVIGATING THE TURN ON THE RAMP BEFORE CONTINUING, HE / SHE ALLEGEDLY COULD NOT GET THE DRIVING TO DEACTIVATE. UPON COMING TO THE TURN IN THE RAMP THE USER INSTEAD CONTINUED FORWARD OFF THE END. AS A CAUSE OF THE APPROXIMATELY 4 FT. FALL WHICH HAD THE CONSEQUENCE OF THE USER'S KNEE IMPACTING INTO THE GROUND, THE USER SUSTAINED A BROKEN HIP IN MULTIPLE PLACES; NO DAMAGE WAS REPORTED TO BE DONE TO THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781575 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY, LLC MX2+ 00861896000303

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization