BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C500

    MDR report key: 7400730 · Received April 5, 2018

    Report

    Report Number
    1221084-2018-00025
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 5, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT FAILURE IS BEING ATTRIBUTED TO STRESSES BEING APPLIED OVER TIME LEADING TO EVENTUAL MATERIAL FATIGUE OF THE TOP PLATE. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA (B)(4)) HAS BEEN IMPLEMENTED TO INVESTIGATE, CORRECT, AND MONITOR EFFECTIVENESS. AS A RESULT OF THE CAPA INVESTIGATION, IT WAS DECIDED THAT A THICKER 8 MM MATERIAL BE USED FOR THE TOP PLATE, REPLACING THE CURRENT 6 MM DESIGN. WITH THIS MATERIAL DESIGN CHANGE, IT WAS DETERMINED THE CHANGE TO THE THICKER MATERIAL IMPROVED THE OVERALL STRENGTH OF THE COMPONENT MAKING IT LESS SUSCEPTIBLE TO MATERIAL FATIGUE WHEN EXPOSED TO LOG TERM STRESSES. THE REDESIGNED COMPONENT HAS BEEN INSTALLED ON THE DEVICE, AND THE CHAIR RETURNED TO THE END-USER. THE DHR WAS REVIEWED AND CHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT WHILE END-USER WAS IN THEIR KITCHEN LOADING THE DISHWASHER, THE TOP PLATE OF THE ELEVATOR STARTED TO SEPARATE FROM THE INNER TUBE CAUSING THE SEATING TO LEAN FORWARD. THIS ALLEGEDLY CAUSED THE END-USER TO LOSE THEIR POSITIONING AND FALL OUT OF THE SEATING. IT WAS REPORTED THE END-USER SUSTAINED FRACTURED RIBS AS A RESULT OF THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243857 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization