BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500

    MDR report key: 6984733 · Received October 27, 2017

    Report

    Report Number
    1221084-2017-00095
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 27, 2017
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS BELIEVED TO HAVE BEEN ATTRIBUTED TO STRESS, LEADING TO EVENTUAL FATIGUE IN THE MATERIAL OF THE UPPER PLATE OF THE ELEVATOR INNER TUBE. DUE TO THE TYPE OF FAILURE MODE OCCURRING, THE AFFECTED COMPONENT IS BEING RETURNED TO PARENT COMPANY FOR MORE IN-DEPTH ANALYSIS AS TO ROOT CAUSE. INVESTIGATIONS CONDUCTED SO FAR SHOW THE REPORTED FAILURE RATE TO BE EXTREMELY LOW. CAPA (B)(4) WAS OPENED TO PROPERLY INVESTIGATE THE ROOT CAUSE AND FORMULATE A CORRECTIVE ACTION. UPON COMPLETION OF CAPA (B)(4), A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED REPORT STATING WHILE END-USER WAS OPERATING THEIR DEVICE AT AN OUTDOOR EVENT, THE SEATING SYSTEM DROPPED AND TILTED FORWARD. NO INJURIES WERE REPORTED TO HAVE OCCURED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764209 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1