BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC MOBILITY

    MDR report key: 9000790 · Received September 11, 2019

    Report

    Report Number
    3003650116-2019-00002
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    March 15, 2019
    Report Date
    September 4, 2019
    Manufacturer
    MAGIC MOBILITY
    Product Code
    ITI
    PMA / PMN Number
    K030783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHEELCHAIR S/N (B)(6) IS A V6 FRONTIER WHICH IS MANUFACTURED BY MAGIC MOBILITY. THE SUBJECT WHEELCHAIR WAS PURCHASED FROM MAGIC MOBILITY BY (B)(4). (B)(4) IS AN APPROVED MAGIC MOBILITY AGENT. THE SUBJECT WHEELCHAIR WAS PURCHASED BY (B)(4) FOR AN END USER. WHEELCHAIR S/N (B)(6) WAS APPROVED FOR RELEASE BY MAGIC MOBILITY 03 NOVEMBER 2017. THE AGE OF THE DEVICE AT THE TIME OF THE INCIDENT WAS APPROXIMATELY 11 MONTHS. END USER REPORTED COMPLAINT TO (B)(4) (B)(6) 2018. END USER ADVISED MAGIC MOBILITY OF INCIDENT (B)(6) 2019. MAGIC MOBILITY REPORTED THE INCIDENT TO THE TGA 10 APRIL 2019 AND TO THE FDA 12 APRIL 2019. TGA MEDICAL DEVICE INCIDENT REPORT (B)(4). PER (B)(6) COMMERCIAL MANAGER (B)(4)) END USER STATES, THE CHAIR STOPS SUDDENLY AT TOP SPEEDS AND THIS IS CAUSING HIS SKIN TO BREAK AND BLEED. END USER REPORTED ADDITIONAL COMPLAINT (B)(6) 2019. PER END USER STATES, FURTHER INJURIES SUSTAINED FROM THE WHEELCHAIR STOPPING, WITH SKIN DAMAGE AND BLEEDING ON HIS SCROTUM AND BUTTOCKS. (B)(4) WERE UNABLE TO IDENTIFY THE CAUSE OF THE DECELERATION DURING THEIR INSPECTION. (B)(4) WERE UNABLE TO REPLICATE THE UNEXPECTED OPERATION OF THE WHEELCHAIR. SCOPE IS LIMITED WHAT CAUSED THE SUBJECT WHEELCHAIR TO DECELERATE WITHOUT USER INPUT. MAGIC MOBILITY REQUESTED THAT THE SUBJECT WHEELCHAIR BE RETURNED TO MAGIC MOBILITY FOR EVALUATION ON 03 APRIL 2019. A SECOND REQUEST FOR THE RETURN OF THE SUBJECT WHEELCHAIR WAS MADE 08 MAY 2019. END USER DECLINED TO RETURN THE SUBJECT WHEELCHAIR ON BOTH REQUESTS. FAILURE ANALYSIS, TECHNICAL EVALUATION AND INSPECTION: INFORMATION PROVIDED BY (B)(4) AND THE END USER WAS ASSESSED TO DETERMINE A PROBABLE CAUSE. REFERENCE FAILURE ANALYSIS REPORT IR0180. THE ASSESSMENT DETERMINED THAT THE MOST PROBABLE CAUSE OF THE DECELERATION OF THE SUBJECT WHEELCHAIR MAY BE RELATED TO USER ACTIVATION OF INHIBIT FUNCTIONS. ADDITIONAL INFORMATION ON THE SUBJECT WHEELCHAIR WAS PROVIDED TO MAGIC MOBILITY SUBSEQUENT TO THE INITIAL ASSESSMENT. IT WAS IDENTIFIED THAT THE SUBJECT WHEELCHAIR HAD BEEN FITTED WITH USER SWITCHES (ALSO REFERRED TO AS BUDDY BUTTONS). MAGIC MOBILITY UNDERTOOK AN ONSITE INSPECTION OF WHEELCHAIR S/N (B)(6) 15 MAY 2019 AND 16 MAY 2019. THE PROBABLE CAUSE OF THE FAILURE (DECELERATION WITHOUT USER INPUT), WAS LIKELY TO STEM FROM THE COMBINED EFFECT OF ALTERATION OF THE JOYSTICK AND MAGNET WITH THE BUDDY BUTTON ON THE SUBJECT WHEELCHAIR. INTERACTION OF THE BUDDY BUTTONS WITH FOREIGN OBJECTS COULD NOT BE RULED OUT. POST-DELIVERY DAMAGE OR ALTERATION: PER (B)(6) ((B)(4) REPRESENTATIVE) THE SWING-BACK JOYSTICK AND MAGNET HAD BEEN ALTERED ON THE SUBJECT WHEELCHAIR POST-DELIVERY TO ASSIST THE END USER WHO HAS PHYSICAL CONSTRAINTS. DESIGN VERIFICATION: WHEELCHAIR FRONTIER V6 (FINISHED PRODUCT) THE FRONTIER V6 WHEELCHAIR WAS TESTED IN ACCORDANCE TO AND SUCCESSFULLY PASSED AS3696, AS3695:1992 AND BS EN 12184:2009 STANDARDS. THE FRONTIER V6 WAS TESTED IN ACCORDANCE TO AND SUCCESSFULLY PASSED ANSI/RESNA STANDARD FOR WHEELCHAIRS. UNAUTHORISED MODIFICATION: (B)(4) ALTERED THE SWING-BACK JOYSTICK AND MAGNET ON WHEELCHAIR S/N (B)(6). (B)(4) ADVISED THE MODIFICATION WAS UNDERTAKEN TO ASSIST THE USER WITH PUSHING THE JOYSTICK AWAY. THE OWNER'S MANUAL (FRONTIER OWNER'S MANUAL 1112) WAS REVIEWED AND THE FOLLOWING INFORMATION IS DISCLOSED ON PAGE 31 SECTION 9 SERVICING: DO NOT MODIFY, OR HAVE YOUR POWER CHAIR MODIFIED IN ANY WAY NOT AUTHORIZED BY MAGIC MOBILITY. UNAUTHORIZED CHANGES CONSTITUTE REMANUFACTURING OF THE WHEELCHAIR. WARNING! UNAUTHORIZED MODIFICATIONS VOID YOUR WARRANTY AND MAY RESULT IN PERSONAL INJURY. STOP! UNAUTHORIZED MODIFICATIONS VOID YOUR WARRANTY, CONSTITUTE REMANUFACTURING AND MAY RENDER YOUR CHAIR UNSAFE. PRODUCT SELECTION: BUDDY BUTTONS INSTALLED ON THE SUBJECT WHEELCHAIR ARE NOT THE RECOMMENDED PENNY GILES BUDDY BUTTONS. THE BUDDY BUTTONS WERE INSTALLED BY THE AGENT (B)(4). CONCLUSION: COMPONENTS ON THE SUBJECT WHEELCHAIR FRONTIER V6 S/N (B)(6) WERE MODIFIED POST-DELIVERY. ALTERATION OF THE JOYSTICK AND MAGNET AND RESULTING VIBRATION MAY CAUSE UNINTENDED ACTIVATION OF THE BUDDY BUTTON. UNINTENDED ACTIVATION OF THE BUDDY BUTTONS BY FOREIGN OBJECTS COULD NOT BE RULED OUT. IN THE OWNER'S MANUAL IT IS STATED THAT UNAUTHORIZED MODIFICATIONS OF THE WHEELCHAIR MAY RENDER THE WHEELCHAIR UNSAFE. MAGIC MOBILITY DID NOT AUTHORISE THE MODIFICATION OF THE FRONTIER V6 S/N (B)(6). THE BUDDY BUTTONS WERE CONFIRMED TO BE NOT THE RECOMMENDED BUDDY BUTTONS. THE MODEL OF BUDDY BUTTONS INSTALLED ON THE SUBJECT WHEELCHAIR MAY NOT BE SUITABLE FOR THE END USER. FOLLOWING REPLACEMENT OF THE BUDDY BUTTONS TO THE RECOMMENDED PENNY GILES BUDDY BUTTON AND TIGHTENING OF THE SWING-BACK JOYSTICK TO REQUIRED STANDARDS, ROOT CAUSE IS IDENTIFIED AS THE COMBINED EFFECT OF IMPROPER ALTERATION AND UNAUTHORISED MODIFICATION OF THE SWING-BACK JOYSTICK AND EFFECT ON THE BUDDY BUTTONS. INAPPROPRIATE SELECTION OF COMPONENT (BUDDY BUTTON) CANNOT BE RULED OUT AS AN INDIRECT CAUSATIVE FACTOR. MODIFICATIONS OF THE WHEELCHAIR UNDERTAKEN BY THE END USER ARE NOT WITHIN THE CONTROL OF MAGIC MOBILITY AND THE RISK OF USE ERROR CANNOT BE MITIGATED ANY FURTHER. THE BUDDY BUTTONS WERE SUPPLIED AND INSTALLED BY A THIRD PARTY. COMPONENT SELECTION BY A THIRD PARTY IS NOT WITHIN THE CONTROL OF MAGIC MOBILITY AND THE RISK TO USER CANNOT BE MITIGATED ANY FURTHER. NO FURTHER INVESTIGATION WILL BE PERFORMED BY MAGIC MOBILITY AT THIS TIME.

    Description of Event or Problem · 0

    PLEASE SEE INITIAL MDR 3003650116-2019-00002.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT MADE AVAILABLE FOR EVALUATION AT THE TIME OF INITIAL SUBMISSION (11APR2019). ON RECEIPT OF FURTHER INFORMATION OR THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL THEN BE ISSUED.

    Description of Event or Problem · 1

    END USER REPORTED (B)(6) 2019 THAT THE DEVICE IS STOPPING INTERMITTENTLY WHEN TRAVELLING AT TOP SPEEDS. PER END USER, THIS CAUSES THE END USER TO SLIDE FORWARD AND THE END USER REPORTS THAT THEY ALMOST TIP OUT OF THE DEVICE. END USER REPORTS THEY HAVE SUSTAINED SKIN DAMAGE FROM THE SLIDING ACTION. END USER HAS SOUGHT MEDICAL ATTENTION FOR THE INJURY SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794146 MAGIC MOBILITY FRONTIER V6 - HYBRID ITI MAGIC MOBILITY FRONTIER V6 HYBRID

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention