BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500

    MDR report key: 6970126 · Received October 23, 2017

    Report

    Report Number
    1221084-2017-00089
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    October 5, 2017
    Report Date
    October 23, 2017
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THE ROOT CAUSE OF THIS FAILURE MODE IS LINKED TO A "COMPONENT FAILURE". PATIENT WAS RECLINING BACK IN THE SEATING SYSTEM, WHEN SLEWING HINGE BROKE AND THE BACKREST FELL BACKWARDS. THE PATIENT USING THE WHEELCHAIR DID NOT SUSTAIN INJURY FROM THIS FAILURE. THE WHEELCHAIR WAS EVALUATED AND COMPONENT FAILURE CONFIRMED. THIS FAILURE MODE IS A KNOWN PROBLEM AND THE SUSPECT COMPONENT HAS BEEN REDESIGNED WITH STRONGER MATERIAL TO PREVENT REOCCURRING FAILURES THAT MAY OCCUR DUE TO STRESS AND FATIGUE. PERMOBIL HAS REPAIRED THE DEVICE WITH NEW REVISION PARTS AND RETURNED THE WHEELCHAIR TO THE PATIENT IN OPERATIONAL CONDITION WITH NO OTHER DEVIATION DISCOVERED. THE DHR FOR THIS DEVICE WAS REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTS FROM (B)(6) ARE THAT THE BACKREST HINGE BROKE WHILE PATIENT WAS IN THE WHEELCHAIR. THE PATIENT WAS NOT INJURED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748670 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500

    Patients

    Seq Age Sex Outcome Treatment
    1