BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C500

    MDR report key: 10479818 · Received September 1, 2020

    Report

    Report Number
    1221084-2020-00044
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    July 6, 2020
    Report Date
    September 1, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL AB RECEIVED REPORT ALLEGING WHILE THE END-USER WAS OPERATING THEIR DEVICE, IT WAS REPORTED TO HAVE TIPPED FORWARD TO WHERE THE END-USER SUSTAINED INJURIES CONSISTING OF 2 BROKEN LEGS. INVESTIGATION CONCLUDED THE ROOT CAUSE OF THE REPORTED EVENT AS BEING ATTRIBUTED TO LACK OF SERVICE/MAINTENANCE IN THAT THE SEAT SIZING HAD NOT BEEN CHANGED TO ACCOMMODATE THE END-USER. IT WAS FOUND THAT THE CURRENT CONFIGURATION OF THE SEATING WAS NOT SET UP TO ACCOMMODATE THE END-USERS CURRENT PHYSICAL PROPORTIONS. SINCE THE DEVICE WAS ORIGINALLY DISTRIBUTED OVER 4 YEARS PRIOR, OVERTIME, THE END-USER HAS HAD AN INCREASE IN WEIGHT AND PROPORTIONS TO WHERE THEY NO LONGER FIT INTO THE SEATING APPROPRIATELY. THIS CAUSED THE USERS POSITIONING TO BE TOO FAR FORWARD IN THE SEATING WHICH ALLOWED THE DEVICE TO TIP FORWARD DUE TO IMPROPER WEIGHT DISTRIBUTION. IT WAS REPORTED THE PRESCRIBER FAILED TO INFORM THE ASSISTIVE TECHNOLOGY CENTRE OF THE USERS WEIGHT INCREASE, THEREFORE THE SEATING WAS NOT PROPERLY ADAPTED TO MEET THE END-USERS CONFIGURATION REQUIREMENTS. AN EVALUATION OF THE WHEELCHAIR WAS CONDUCTED TO WHICH THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO OPERATIONAL MALFUNCTIONS BEING NOTED. THE DHR WAS REVIEWED AND THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING WHILE THE END-USER WAS OPERATING THE DEVICE, IT WAS ALLEGED TO HAVE TIPPED FORWARD WHICH CAUSED THE END-USER TO SUFFER INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942647 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization