BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C350

    MDR report key: 7125727 · Received December 18, 2017

    Report

    Report Number
    1221084-2017-00108
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 18, 2017
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K071650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 SUPPLIED TO THE SERVICE PROVIDER, 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 THE END-USER WAS TRAVERSING DOWN A SIDEWALK AND MANEUVERED THE CHAIR OVER AN 1/2"-3/4" OBSTACLE. IT WAS REPORTED THAT AFTER HITTING THAT OBSTACLE, THE UPPER PLATE OF THE FST BROKE FREE ALLOWING THE SEATING AND CLIENT TO START TO FALL. REPORTS ARE THE END-USERS HUSBAND RESPONDED QUICKLY, CATCHING THE END-USER BEFORE THE SEATING FELL FROM THE CHASSIS. NO INJURIES WERE REPORTED TO HAVE BEEN SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905065 PERMOBIL C350 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C350 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1