BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL CHAIRMAN KOALA

    MDR report key: 7847300 · Received September 5, 2018

    Report

    Report Number
    1221084-2018-00050
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 5, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K960951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO MANUFACTURER FOR EVALUATION WITH THE RESULTS OF THE INSPECTION CONCLUDING THE DEVICE TO BE FULLY FUNCTIONAL WITH NO ABNORMALITIES OR DEVIATIONS BEING NOTED. SYSTEM LOG HISTORY WAS REVIEWED WITH NO ENTRIES PRESENT THAT WOULD INDICATE A SYSTEM ERROR HAVING OCCURRED. REVIEW OF THE BASE PROGRAM FILE DID NOT INDICATE ANY IRREGULARITIES WITHIN THE PARAMETER SETTINGS I.E. SPEED AND ACCELERATION, ALL OF WHICH WERE SET AT THE STANDARD FACTORY SETTINGS. INTERVIEWS WITH PERSONNEL CLOSE TO THE END-USER INDICATE THE END-USER HAS BEEN NOTED AS BEING "LESS SKILLED" WHILE OPERATING THE DEVICE. THE DEVICE IS BEING RETURNED TO THE END-USER WITH THE RECOMMENDATION GIVEN TO THE SERVICE PROVIDER TO RE-EVALUATE THE END-USER'S CAPABILITIES DURING OPERATION OF THE DEVICE AND TO ADJUST DRIVE PARAMETERS TO MEET THE USER'S CURRENT SKILL LEVEL. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT STATING THE END-USER WAS TRAVERSING IN A PARKING LOT IN THEIR DEVICE. WHEN THEY RELEASED THE JOYSTICK CONTROL TO STOP, THE DEVICE ALLEGEDLY CONTINUED TO DRIVE CAUSING THE END-USER TO STRIKE THE BUMPER OF A SCHOOL BUS WITH FORCE. REPORTS INDICATE THE END-USER SUFFERED A FRACTURED LEG AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687744 PERMOBIL CHAIRMAN KOALA POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) KOALA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization