BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 4336236 · Received December 3, 2014

    Report

    Report Number
    3008370857-2014-00001
    Event Type
    Injury
    Date Received
    December 3, 2014
    Date of Event
    June 30, 2014
    Report Date
    November 26, 2014
    Manufacturer
    MAX MOBILITY, LLC
    Product Code
    ITI
    PMA / PMN Number
    K113621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAX MOBILITY'S ANALYSIS OF THE EVENT ARE: THE DEVICE FUNCTIONED AS DESIGNED AND EXPECTED. UPON INSPECTION OF THE MANUFACTURING RECORDS, THE DEVICE FROM THE ADVERSE INCIDENT (SERIAL NUMBER (B)(4)) WAS MANUFACTURED TO SPECIFICATION, PASSED ALL QUALITY CHECKS, AND WAS RELEASED AFTER FINAL TESTING OF THE DEVICE WAS PERFORMED. THERE IS A PHYSICAL STOP BUILT INTO THE ATTACHING INTERFACE OF THE DEVICE THAT PREVENTS THE REAR WHEELS FROM BEING LIFTED MORE THAN 1 INCH OFF THE GROUND. THE SMARTDRIVE IS ALWAYS PUSHING UPWARDS ON THE USERS WHEELCHAIR. IT USES THIS TO ACCOMPLISH TRACTION. IF THE USER'S WEIGHT IS REMOVED FORM THE SEAT, THE SMARTDRIVE'S DRIVING FORCES WILL LIFT UP THE WHEELCHAIR SEAT. THE FACT THAT THE SMARTDRIVE LIFTED HIS SEAT UP DURING THE COLLISION AND NOT DURING EVERYDAY USE INDICATES THAT HIS WEIGHT WAS ALREADY LIFTED FORM THE SEAT AND HE WAS IN THE PROCESS OF FALLING FORWARD OUT OF THE WHEELCHAIR SEAT AS A RESULT OF THE COLLISION, NOT AS A RESULT OF THE SMARTDRIVE TILTING HIS SEAT FORWARD. HE WOULD HAVE FELL OUT REGARDLESS OF THE CONTINUAL DRIVING OF THE SMARTDRIVE OR NOT. THERE ARE MANY INSTANCES WHERE A WHEELCHAIR USE CAN HIT A CRACK (I.E. IN A SIDEWALK) AND BE EJECTED FORWARD OUT ONTO THE GROUND. THE PRIMARY FACTORS THAT LEAD TO THESE INCIDENCES ARE RELATED TO THE WHEELCHAIR ITSELF, AND ARE OPERATOR ERROR, CASTER DIAMETER BEING TOO SMALL FOR THE ENVIRONMENT, AND TOO MUCH WEIGHT DISTRIBUTED ON THE FRONT CASTERS VERSES THE LARGE REAR WHEELS. THESE INCIDENCES CAN OCCUR REGARDLESS OF WHETHER A USER HAS A SMARTDRIVE (OR ANY POWER ASSIST / POWER ADD-ON DEVICE) OR NOT. THE ADVERSE EVENT CAN BE CONTRIBUTED TO A COMBINATION OF OPERATOR ERROR, INSUFFICIENT WHEELCHAIR CASTER DIAMETER AND/ OR THE BEHAVIOR OF THE WHEELCHAIR AS EFFECTED BY THE LOCATION OF THE CENTER OF GRAVITY OF THE USER RELATIVE TO THE LOCATION OF THE REAR WHEELS. IN CONCLUSION OF THE INVESTIGATION, IT HAS BEEN ASSESSED THAT THE DEVICE HAS BEEN DESIGNED TO REDUCE THE AMOUNT OF RISK OF THIS EVENT AS FAR AS POSSIBLE, THE DESIGN IS SAFE, THE UNIT WAS MANUFACTURED TO SPECIFICATION, SUFFICIENT WARNING / INSTRUCTION FOR THIS TYPE OF EVENT WAS GIVEN, AND IT FUNCTIONED AS EXPECTED IN THE SITUATION.

    Description of Event or Problem · 1

    AS DESCRIBED TO MAX MOBILITY FROM THE "ADVERSE INCIDENT REPORT" AND THE DISTRIBUTOR OF THE DEVICE IN THE (B)(4), THE USER WAS USING HIS QUICKIE HELIUM MANUAL WHEELCHAIR WITH HIS SMARTDRIVE ATTACHED/DRIVING IN "OUTDOOR MODE," WHEN HIS FRONT CASTERS HIT AN OBSTACLE IN THE PAVEMENT. THIS CAUSED THE WHEELCHAIR AND THE USER TO TIP FORWARD, RESULTING IN THE USER TO BE TILTED OUT OF HIS WHEELCHAIR. AS DESCRIBED TO MAX MOBILITY FROM THE "ADVERSE INCIDENT REPORT: AND THE DISTRIBUTOR OF THE DEVICE IN THE (B)(4), THE USER/PT BROKE HIS FEMUR THIS LEAD TO HOSPITALIZATION AND ENDING WITH THE USER HAVING TO HAVE THE TOP OF HIS FEMUR AND BALL JOINT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779517 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY, LLC MX1+

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S