BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F3

    MDR report key: 9226570 · Received October 23, 2019

    Report

    Report Number
    1221084-2019-00048
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    September 3, 2019
    Report Date
    October 23, 2019
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL AB RECEIVED REPORT CLAIMING THE DEVICE SUDDENLY STOPPED, WITHOUT WARNING, CAUSING THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE SEATING TO THE GROUND. REPORTS CLAIM THE END-USER RECEIVED INJURIES CONSISTING OF 2 BROKEN TEETH AND A LACERATION TO THE CHIN REQUIRING STITCHES. THE FAMILY REPORTED THE DEVICE REMAINED POWERED ON, BUT WAS UNABLE TO DRIVE UNTIL POWER WAS CYCLED VIA THE JOYSTICK. IT WAS ALSO REPORTED AN ERROR MESSAGE WAS DISPLAYED ON THE JOYSTICK, BUT IT WAS NOT NOTED AS TO WHAT THE CODE WAS. THE DEVICE WAS RETRIEVED BY THE SERVICE PROVIDER AND STORED AT THEIR LOCATION UNTIL PERMOBIL TECHNICIANS COULD INSPECT THE DEVICE. PERMOBIL'S EVALUATION SHOWN THE DEVICE TO BE FULLY OPERATIONAL WITH NO NOTABLE PHYSICAL, ELECTRICAL OR MECHANICAL DEVIATIONS. REVIEW OF THE SYSTEM LOG SHOWN THE LAST RECORDED ENTRY BEING 1D05 "JOYSTICK STATIONARY TIME EXCEEDED". THIS OCCURS WHEN THE JOYSTICK IS DEEMED TO HAVE BEEN HELD STATIONARY FOR AN EXCESSIVE PERIOD OF TIME. THE CONTROLLER WILL STOP DRIVE TO PREVENT POSSIBLE DAMAGE THE WHEELCHAIRS MOTORS. TURNING THE CONTROL SYSTEM OFF AND ON AGAIN WILL CLEAR THIS ERROR MESSAGE. THE DEVICE WAS PUT THROUGH FULL OPERATIONAL TESTS IN ATTEMPTS TO REPRODUCE THE REPORTED ANOMALY, TO WHICH ALL ATTEMPTS WERE UNSUCCESSFUL. UPON COMPLETION OF THE EVALUATION, PERMOBIL CANNOT MAKE A CLEAR DETERMINATION AS TO HOW OR WHY THE DEVICE STOPPED AS REPORTED. THE DHR WAS REVIEWED AND THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION. THE DEVICE HAS BEEN RETURNED TO THE SERVICE PROVIDER TO BE RE-DELIVERED TO THE END-USER.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS END-USER WAS DRIVING THE DEVICE, THE DEVICE ALLEGEDLY STOPPED CAUSING THE END-USER TO LOSE THEIR POSITIONING AND FALL OUT OF THE SEATING TO THE GROUND. REPORTS INDICATE THE END-USER RECEIVED INJURIES REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019997 PERMOBIL F3 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization