BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M400

    MDR report key: 10442266 · Received August 24, 2020

    Report

    Report Number
    1221084-2020-00040
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 24, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS PROVIDED CLAIM THE END-USER FORGOT TO TURN OFF THE WHEELCHAIR AND ACCIDENTALLY ENGAGED A DRIVE COMMAND. THIS RESULTED IN THE DEVICE ACCELERATING FORWARD TO WHERE IT EVENTUALLY COLLIDED INTO A WALL. THE IMPACT WAS REPORTED TO CAUSE THE FOOTPLATES TO FLIP UPWARDS RESULTING IN FRACTURES TO BOTH ANKLES. PERMOBIL HAS DETERMINED ROOT CAUSE OF THIS EVENT AS BEING ATTRIBUTED TO "USE ERROR". REPORT CLAIMS THE INCIDENT WAS STRICTLY USE ERROR IN FAILURE TO POWER DOWN THE DEVICE WHEN NOT IN USE. NO ALLEGATIONS OR CLAIMS WERE MADE OF A DEVICE MALFUNCTION HAVING OCCURRED. IT IS ALSO REPORTED THE END-USER HAS REPEATEDLY FORGOTTEN TO TURN OFF THE DEVICE DESPITE CONSTANT REMINDERS. WHEELCHAIR WAS EVALUATED AND FOUND TO BE FULLY OPERATIONAL WITH NO FAULTS FOUND. IN EFFORTS TO PREVENT ANY FUTURE OCCURRENCES, PERMOBIL SUGGESTED UPDATING JOYSTICK CONFIGURATION TO INCLUDE A "SLEEP TIMER" THAT WOULD TURN THE DEVICE OFF (OVER A DESIRED TIMESPAN) OF NON-USE, BUT THIS WAS REFUSED BY THE END-USER DUE TO THEIR HIGHLY ACTIVE LIFESTYLE. DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO INITIAL DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS THE END-USER WAS WORKING AT THE DAY CENTER, THEY INADVERTENTLY FORGOT TO TURN OFF THE POWER TO THE WHEELCHAIR. AS THE END-USER MOVED SOMETHING ON THEIR TRAY, THE OBJECT REPORTEDLY ENGAGED THE JOYSTICK BY ACCIDENT WHICH THEN CAUSED THE WHEELCHAIR TO DRIVE FORWARD EVENTUALLY IMPACTING A WALL. THE IMPACT REPORTEDLY CAUSED THE FOOTPLATES TO FLIP UPWARDS WHICH LED TO INJURY OF BOTH ANKLES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910787 PERMOBIL M400 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) M400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization