BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL F5 CORPUS VS

    MDR report key: 22416583 · Received July 7, 2025

    Report

    Report Number
    1221084-2025-00008
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 7, 2025
    Manufacturer
    PERMOBIL AB
    Product Code
    IPL
    PMA / PMN Number
    K191874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED REPORT THAT AS WHILE THE END-USER WAS DRIVING THEIR MOTOR VEHICLE WHILE POSITIONED IN THE POWER WHEELCHAIR, REPORTS THE BACKREST OF THE DEVICE FELL BACKWARD WHICH FORCED THE END-USER TO LOSE UPRIGHT POSITIONING AND LAY FLAT. NO INJURIES WERE REPORTED TO HAVE OCCURRED. IMAGES PROVIDED OF THE DEVICE INDICATE THE FASTENERS USED TO SECURE THE BACKPLATE TO THE HINGE HAD BROKEN, WHICH ALLOWED THE BACKREST ASSEMBLY TO FALL TO A HORIZONTAL POSITION. AT THIS POINT IN THE INVESTIGATION, PERMOBIL IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE HARDWARE FAILURE WITHOUT SPECULATION. IF PERMOBIL AB RECEIVES ANY NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    RECEIVED REPORT THAT AS WHILE THE END-USER WAS DRIVING THEIR MOTOR VEHICLE WHILE POSITIONED IN THE POWER WHEELCHAIR, REPORTS THE BACKREST OF THE DEVICE FELL BACKWARD WHICH FORCED THE END-USER TO LOSE UPRIGHT POSITIONING AND LAY FLAT. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706 PERMOBIL F5 CORPUS VS POWERED WHEELCHAIR IPL PERMOBIL AB F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown