BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M400

    MDR report key: 10819838 · Received November 10, 2020

    Report

    Report Number
    1221084-2020-00051
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 10, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INSPECTED AND EVALUATED BY PERMOBIL TECHNICIANS WHO FOUND THE DEVICE TO BE FULLY OPERATIONAL WITH NO MECHANICAL OR ELECTRICAL MALFUNCTIONS BEING NOTED. INSPECTION SHOWN THE LATERAL SUPPORTS WERE ADJUSTED IN SUCH A WAY THAT THE JOYSTICK, WHEN PANEL HOLDER WAS RETRACTED INWARD, WOULD CONTACT THE LATERAL SUPPORT. REPORTS PROVIDED CLAIM THE END-USER SUFFERS FROM INVOLUNTARY SPASMS AND WHEN THESE OCCUR, THEY HAVE TENDANCY TO PULL THE JOYSTICK INWARDS TOWARDS THEIR BODY. THIS ACTION WOULD CAUSE THE JOYSTICK TO CONTACT THE LATERAL SUPPORT PAD, FORCING THE JOYSTICK INDUCTIVE INTO A FORWARD POSITION CAUSING THE DEVICE TO DRIVE. WITH THE INFORMATION PROVIDED, PERMOBIL DETERMINED THIS EVENT AS BEING CAUSED BY INADVERTENT USE ERROR. IN EFFORT TO MITIGATE ANY FUTURE RECURRENCES, PERMOBIL HAS RECOMMENDED THE PROVIDER REPLACE THE RETRACTABLE STYLE PANEL HOLDER WITH A FIXED PANEL HOLDER, OR REPOSITION THE LATERAL SUPPORTS TO WHERE THE JOYSTICK WOULD NOT CONTACT IF THE END-USER UNWILLINGLY RETRACTS DUE TO THEIR CONDITION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING WHILE THE END-USER WAS DRIVING THEIR DEVICE STRAIGHT AHEAD, THEY RELEASED THEIR GRIP ON THE JOYSTICK IN EFFORT TO STOP THE DEVICE. THE END-USER ALLEGED THE DEVICE CONTINUED TO DRIVE STRAIGHT, WITHOUT COMMAND, EVENTUALLY CAUSING THE DEVICE TO IMPACT A STONE STATUE. REPORTS INDICATE THE END-USER SUSTAINED INJURIES REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280994 PERMOBIL M400 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) M400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization