BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C500 CORPUS

    MDR report key: 11783282 · Received May 6, 2021

    Report

    Report Number
    1221084-2021-00018
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    December 28, 2020
    Report Date
    May 6, 2021
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE CONFIRMED THE TOP PLATE THAT SECURES THE SEATING TO THE ELEVATOR HAVING DETACHED FROM WHERE IT ATTACHED TO THE ELEVATOR INNER TUBE. WHEN THIS OCCURED, IT REPORTEDLY CAUSED THE SEATING TO FALL OVER TO THE SIDE LANDING ON THE GROUND. REPORTS INDICATE THE END-USER DID NOT INCUR ANY SERIOUS INJURIES, HAVING SUFFERED MINOR BRUISING TO THEIR SHOULDER THAT DID NOT NECESSITATE MEDICAL INTERVENTION. 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 0014) HAS BEEN IMPLEMENTED TO INVESTIGATE, CORRECT, AND MONITOR EFFECTIVENESS. AS A RESULT OF THE CAPA INVESTIGATION, IT WAS DECIDED THAT A THICKER 8MM MATERIAL BE USED FOR THE TOP PLATE, REPLACING THE CURRENT 6MM 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 THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    PERMOBIL AB RECEIVED A REPORT CLAIMING AS THE END-USER WAS IN PROCESS OF PERFORMING A TRANSFER, THE SEATING ALLEGEDLY DETACH AND FELL OFF TO THE SIDE TO THE GROUND. REPORTS INDICATE THE END-USER SUSTAINED MINOR INJURIES THAT DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679256 C500 CORPUS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1