BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 14435925 · Received May 19, 2022

    Report

    Report Number
    3008370857-2022-00002
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    April 16, 2022
    Report Date
    September 29, 2022
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    END-USER REPORTS AS THEY WERE CROSSING A STREET IN THEIR MANUAL WHEELCHAIR, THE ATTACHED SMARTDRIVE POWER ASSIST UNIT POWERED ON TO ENGAGE A DRIVE, WITHOUT COMMAND, PROPELLING THE WHEELCHAIR W/END-USER AT SPEED. CLAIMS MADE THAT END-USER ATTEMPTED TO DISABLE DRIVE BY PRESSING THE ATTACHED SWITCHES, BUT THE COMMAND DID NOT STOP THE UNIT. REPORTS INDICATE THE DEVICE CONTINUED TO PROPEL UNTIL THE WHEELCHAIR IMPACTED A RETAINING WALL. THE IMPACT CAUSED THE END-USER TO LOSE POSITIONING AND FALL TO THE GROUND. END-USER REPORTS HAVING DISLOCATED THEIR SHOULDER BUT REPOSITIONED IT THEMSELVES. END-USER STATED THEY DID NOT SEEK MEDICAL INTERVENTION AS THEY ARE SUSCEPTIBLE TO DISLOCATION AND ARE ACCUSTOMED TO RESOLVE ON THEIR OWN. THE END-USER REPORTS HAVING REPLACED THE SWITCH SET APPROXIMATELY 2 WEEKS PRIOR TO THE EVENT AND HAVE BEEN HAVING INTERMITTENT ISSUES SINCE INSTALLATION. OUT OF AN ABUNDANCE OF CAUTION, PERMOBIL HAS REPLACED THE SMARTDRIVE UNIT AND SWITCH SET WITH NEW AND IS PLANNING FOR THE SUSPECT COMPONENTS BE RETURNED TO PERMOBIL FOR INSPECTION/EVALUATION IN EFFORT TO DETERMINE A POSSIBLE ROOT CAUSE. AT THIS TIME PERMOBIL HAS NOT RECEIVED THE SUSPECT COMPONENTS THEREFORE A DETERMINATION CANNOT BE MADE. WHEN NEW INFORMATION IS RECEIVED, PERMOBIL WILL SUBMIT A FOLLOW-UP REPORT WITH THEIR FINDINGS. THE DHR WAS REVIEWED AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    DUE TO THE REPORT OF AN INJURY HAVING OCCURRED BECAUSE OF A CONFIRMED COMPONENT FAILURE, A CAPA INVESTIGATION WAS INITIATED. A REVIEW OF THE HAZARD RISK ANALYSIS WAS CONDUCTED, AND THIS FAILURE MODE WAS FOUND TO REMAIN LOW, HOWEVER PERMOBIL WILL CONTINUE TO MONITOR ANY FURTHER REPORTS THROUGH TREND ANALYSIS AND TAKE APPROPRIATE ACTIONS. FURTHER ANALYSIS OF COMPONENTS, SWITCH CONTROL BUTTON ASSEMBLY AND SMARTDRIVE UNIT, WERE RETURNED TO PERMOBIL FOR INSPECTION/EVALUATION WAS CONDUCTED. OPERATIONAL TESTING OF SWITCH CONTROL BUTTONS CONFIRMED THE REPORT OF INVOLUNTARY ACTIVATION OF DRIVE MOTOR WITHOUT THE NEED TO DEPRESS THE BUTTON, AND THE FAILURE TO DISENGAGE MOTOR ONCE DEPRESSED.

    Description of Event or Problem · 0

    END-USER REPORTED WHILE CROSSING STREET IN THEIR MANUAL WHEELCHAIR, EQUIPPED WITH A SMARTDRIVE POWER ASSIST UNIT, THE SMARTDRIVE UNIT WAS REPORTED TO HAVE ENGAGED DRIVE, WITHOUT COMMAND, AND ACCELERATED AT FULL SPEED. REPORTS CLAIM THE UNIT WOULD NOT STOP WHEN GIVEN COMMAND VIA SWITCHES AND THE WHEELCHAIR CONTINUED TO DRIVE CAUSING THE WHEELCHAIR TO IMPACT INTO A RETAINING WALL. THIS RESULTED IN THE END-USER FALLING OUT OF THE WHEELCHAIR SEATING RESULTING IN AN INJURY TO THE END-USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343128 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other