BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C500 CORPUS 3G

    MDR report key: 17932133 · Received October 13, 2023

    Report

    Report Number
    1221084-2023-00021
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 13, 2023
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION PROVIDED TO PERMOBIL AB INDICATED THE END-USER MOVED THE WHEELCHAIR TO THE BED AND POSITIONED THE SEAT AND FOOTREST TO THE SAME HEIGHT AS THE TOP OF THE BED. AS THE END-USER STARTED TO TRANSFER FROM THE WHEELCHAIR'S SEAT TOWARDS THE BED, THE FOOTPLATE ASSEMBLY REPORTEDLY DETACHED AND FELL ON THE FLOOR WHILE THE USER'S FEET WERE ON THE BED, AND THEIR LEGS RESTING ON THE FOOTPLATE. THE END-USER CLAIMS TO HAVE RECEIVED SMALL FRACTURES TO THEIR HIP AS THEIR LEGS WERE SUDDENLY UNSUPPORTED. THE REPORT OF SMALL FRACTURES IN THE HIP IS BASED SOLELY ON THE END-USER'S SELF-DIAGNOSIS AS THEY CONFIRMED NOT HAVING SOUGHT MEDICAL ATTENTION. PERMOBIL TECHNICIANS WERE DISPATCHED TO EVALUATE THE DEVICE. IT WAS FOUND THAT SCREWS USED TO SECURE THE FOOTPLATE ASSEMBLY HAD LOOSENED WHICH ALLOWED THE FOOTPLATE ASSEMBLY TO SLIDE OFF THE LEG TUBE FROM WHICH IT WAS ATTACHED. THE ASSEMBLY WAS RE-INSTALLED, ADJUSTED TO CLIENTS' NEEDS, AND SECURED ACCORDINGLY. IT IS PERMOBIL AB'S DETERMINATION THAT THIS REPORTED INCIDENT WAS THE RESULT OF LACK OF MAINTENANCE WHERE THE SECURING HARDWARE HAD LOOSENED, OVER TIME, AFTER NORMAL USE. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING AS THE END-USER WAS IN TRANSITION OF TRANSFERRING FROM THE WHEELCHAIR'S SEATING TO THE BED, THE FOOTPLATE ASSEMBLY REPORTEDLY FELL OFF. THIS REPORTEDLY CAUSED THE END-USER TO LOSE SUPPORT TO THEIR LEGS AND RESULTED IN A SELF-DIAGNOSED INJURY. MEDICAL INTERVENTION WAS NOT SOUGHT TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631598 PERMOBIL C500 CORPUS 3G POWERED WHEELCHAIR ITI PERMOBIL AB C500 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other