BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS

    MDR report key: 19723989 · Received July 11, 2024

    Report

    Report Number
    1221084-2024-00011
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 11, 2024
    Manufacturer
    PERMOBIL AB
    Product Code
    IPL
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED REPORT OF THE ARMREST HAVING FALLEN DOWN AS THE END-USER WAS APPLYING PRESSURE WHILST REACHING FOR AN OBJECT. REPORT INDICATES THE END-USER LOST POSITIONING AND FELL FROM THE SEATING WHICH RESULTED IN THEIR HAVING SUSTAINED A FRACTURED HIP. INSPECTION OF THE DEVICE CONFIRMED A FAILURE HAVING OCCURRED TO THE THREADED LINK ROD THAT IS USED FOR ANGLE ADJUSTMENT OF THE ARMRESTS. THE FAILURE WAS REPORTED AS HAVING OCCURRED AT THE END OF THE ROD WHERE IT CONNECTS TO THE ARMREST TO WHERE THE THREADED ROD BROKE AT THE CONNECTION POINT. REVIEW OF CLIENT FILE DOES NOT SHOW ANY HISTORY OF THIS COMPONENT HAVING BEEN SERVICED SINCE INITIAL DISTRIBUTION IN 2018, LEADING PERMOBIL TO DEDUCE THE FAILURE AS BEING CAUSED BY STRESS, OVER 7 YEARS, LEADING TO EVENTUAL MATERIAL FATIGUE. THE DHR WAS REVIEWED, AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING WHILE THE END-USER WAS LEANING ON THE ARMREST WHILE ATTEMPTING TO REACH FOR SOMETHING, THE ARMREST REPORTEDLY FELL DOWNWARDS WHICH CAUSED THE END-USER TO LOSE POSITIONING AND FALL FROM THE SEATING, RESULTING IN AN INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380935 PERMOBIL F5 CORPUS POWERED WHEELCHAIR IPL PERMOBIL AB F5 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization