BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C500

    MDR report key: 7937747 · Received October 5, 2018

    Report

    Report Number
    1221084-2018-00061
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    December 3, 2017
    Report Date
    October 5, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS CLAIM THE CHAIR ROLLED UNCONTROLLABLY DOWN A RAMP TO WHERE AT THE BOTTOM THE CHAIR TIPPED CAUSING THE END-USER LOSE POSITIONING IN THE SEATING AND FALL TO THE GROUND SUFFERING INJURIES TO INCLUDE A FRACTURED LEFT TIBIA AND FIBULA. REPORTS ARE THE END-USER WAS NOT WEARING THE INSTALLED POSITIONING BELT AT THE TIME OF THE EVENT. THE DEVICE WAS RETURNED TO PERMOBIL (B)(4) FOR EVALUATION. OPERATIONAL TESTING OF DEVICE ON AN 8° INCLINE SHOWN THE DEVICE TO ROLL APPROXIMATELY 6-8" BEFORE COMING TO A STOP AFTER THE JOYSTICK WAS RELEASED. THE REPORTS OF THE DEVICE CONTINUING TO ROLL UNCONTROLLABLY WHILE ON AN INCLINE WAS UNABLE TO BE DUPLICATED. THE DEVICE STOPPED AND HELD UNDER TESTING WITH RAMP ANGLES OF THE SAME DEGREE AS EVENT SITE OR GREATER. TESTING OF THE DEVICE INDICATED POTENTIAL MOTOR WEAR, BUT IS NOT BEING CONSIDERED AS EXCESSIVE FOR SAFE USE. MOTOR COMPENSATIONS AS WELL AS PARAMETER SETTINGS CAN BE ADJUSTED TO DECREASE THE AMOUNT OF TIME (ROLL) FOR COMPLETE STOPPAGE OF THE DEVICE. DUE TO THE EVENT HAVING OCCURRED OUT OF DOORS IN THE MONTH OF (B)(6), ENVIRONMENTAL FACTORS WERE NOT ABLE TO BE REPRODUCED, BUT WERE TAKEN INTO CONSIDERATION AS BEING A POSSIBLE CONTRIBUTING FACTOR. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT STATING END-USER WAS IN THEIR WHEELCHAIR ATTEMPTING TO ENTER A WHEELCHAIR ACCESSIBLE MOTOR VEHICLE. IT WAS REPORTED THAT DURING THIS TRANSITION, THE WHEELCHAIR ALLEGEDLY ROLLED TO THE BOTTOM OF THE RAMP, UNCONTROLLABLY, TO WHERE IT STARTED TO TIP CAUSING THE END-USER TO LOSE POSITIONING IN THE SEATING AND FALL TO THE GROUND TO WHERE INJURIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779871 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization