BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M400

    MDR report key: 14601050 · Received June 6, 2022

    Report

    Report Number
    1221084-2022-00010
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    February 26, 2022
    Report Date
    June 6, 2022
    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 · 0

    REPORT RECEIVED CLAIMED AS THE CAREGIVER WAS DRIVING THE DEVICE FROM THE REAR VIA A CO-PILOT ATTENDANT CONTROL, WHEN ATTEMPTING TO GO THROUGH A DOORWAY, THE DEVICE REPORTEDLY "SKIPPED" TO THE SIDE WHICH ALLOWED THE END-USER'S FOOT TO CATCH THE DOOR FRAME. 3 DAYS AFTER THE EVENT THE END-USER NOTICED SWELLING IN THEIR LOWER RIGHT LEG, AND THEY SOUGHT MEDICAL INTERVENTION WHERE THEY WERE DIAGNOSED AS SUSTAINING A FRACTURE TO THEIR RIGHT TIBIA. PERMOBIL TECHNICIANS EVALUATED THE DEVICE AND VERIFIED IT WAS FULLY OPERATIONAL WITH NO SIGNS OF A MALFUNCTION HAVING OCCURRED. IT WAS NOTED THAT VARIOUS COMPONENTS OF THE CO-PILOT WERE LOOSE AND SLIGHTLY OUT OF POSITION, BUT IT WAS SURMISED THAT THOSE FINDINGS WOULD NOT HAVE AFFECTED THE HANDLING OF THE DEVICE. ALL THE FINDINGS WERE CORRECTED, AND DEVICE WAS OPERATIONALLY TESTED SATISFACTORY. IT IS PERMOBIL'S CONCLUSION THAT THE EVENT WAS INADVERTENT USE ERROR ON THE CAREGIVER BY INADVERTENTLY MANEUVERING THE DEVICE TO CLOSE TO THE DOOR FRAME. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    REPORT RECEIVED CLAIMING THE CAREGIVER WAS OPERATING THE DEVICE FROM THE REAR WHILST USING THE CO-PILOT ATTENDANT CONTROL. WHEN ATTEMPTING TO GUIDE THE DEVICE THROUGH A DOORWAY, THE DEVICE REPORTEDLY SKIPPED TO THE SIDE. THIS ACTION REPORTEDLY CAUSED THE END-USER RIGHT FOOT TO CATCH THE DOOR FRAME WHERE THEY SUSTAINED AN INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2411994 PERMOBIL M400 POWER WHEELCHAIR ITI PERMOBIL AB (PAB) M400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization