BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 8220287 · Received January 4, 2019

    Report

    Report Number
    3008370857-2019-00001
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 8, 2018
    Report Date
    January 4, 2019
    Manufacturer
    MAX MOBILITY, LLC
    Product Code
    ITI
    UDI-DI
    00861896000303
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 1/4/2019 MAX MOBILITY HAD NOT RECEIVED THE SPECIFIC DEVICE (SERIAL NUMBER (B)(4)). INITIAL ASSESSMENT BY MANAGEMENT, BARRING ANY ADDITIONAL INFORMATION, IS THAT THE DEVICE LIKELY DID NOT MALFUNCTION (LIKELY ENVIRONMENTALLY, FAILURE TO FOLLOW INSTRUCTIONS, AND / OR USE ERROR CAUSED OR CONTRIBUTED TO EVENT); BUT THIS IS SPECULATIVE. 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. 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 10/20/2015. SO THE DATE OF 12/10/2018 AS THE FIRST OF MAX MOBILITY BECAME AWARE HOLDS TRUE AND THE HANDLING OF EVERYTHING ACCORDING TO THE ESTABLISHED QUALITY SYSTEM PROCEDURES WAS VERIFIED. MAX MOBILITY CONTINUES TO ATTEMPT TO COLLECT MORE INFORMATION FROM THE USER AS WELL AS HAVE THE UNIT RETURNED FOR EVALUATION / INVESTIGATION. AS APPLICABLE ALL FOLLOW-UP REPORTING WILL BE COMPLETED AND SUBMITTED ACCORDINGLY. IT CAN BE NOTED THAT ALL MODELS 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).

    Description of Event or Problem · 1

    AS DESCRIBED TO THE SALES REPRESENTATIVE BY THE USER'S REHAB COORDINATOR, USER WAS OPERATING SMARTDRIVE MODEL MX2 AND HE / SHE ALLEGEDLY COULD NOT GET THE DRIVING TO DEACTIVATE. UPON ATTEMPTING TO STOP THE UNIT MANUALLY, THE USER WAS THROWN FROM THE WHEELCHAIR. AS A CAUSE OF BEING EJECTED FROM THE WHEELCHAIR THE USER SUSTAINED A BROKEN LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9476 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY, LLC MX2 00861896000303

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization