BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F3

    MDR report key: 8587739 · Received May 7, 2019

    Report

    Report Number
    1221084-2019-00016
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 7, 2019
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL (B)(4) RECEIVED REPORT CLAIMING THE DEVICE SUDDENLY STOPPED, WITHOUT WARNING, CAUSING THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE SEATING TO WHICH THEY ALLEGE THE DEVICE DROVE OVER THEIR LEGS RESULTING IN FRACTURES. REPORTS CLAIM THE END-USER WAS DRIVING THE DEVICE ON A FLAT, LEVEL SURFACE WHEN THIS INCIDENT OCCURRED. THE DEVICE WAS RETRIEVED BY THE SERVICE PROVIDER AND STORED AT THEIR LOCATION UNTIL PERMOBIL TECHNICIANS COULD INSPECT THE DEVICE. INSPECTION SHOWN THE DEVICE TO BE FULLY OPERATIONAL WITH NO NOTABLE PHYSICAL OR MECHANICAL DEVIATIONS. A FULL EVALUATION OF THE ELECTRICAL SYSTEM, WITH A FOCUS PRIMARILY ON THE ELECTRO - MAGNETIC BRAKE SYSTEM, DID NOT SHOW ANY ABNORMALITIES OR DEVIATIONS. THE DEVICE WAS PUT THROUGH FULL OPERATIONAL TESTS WITHOUT ANY DEVIATIONS BEING NOTED. UPON COMPLETION OF THE EVALUATION, PERMOBIL COULD NOT CONFIRM NOR PROVIDE A TECHNICAL DETERMINATION AS TO HOW OR WHY THE DEVICE ALLEGEDLY STOPPED AS REPORTED. THE DHR WAS REVIEWED AND THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION. THE DEVICE HAS BEEN RETURNED TO THE SERVICE PROVIDER TO BE RE-DELIVERED TO THE END-USER.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS END-USER WAS DRIVING ALONG A FLAT SURFACE WHILE INDOORS, IT WAS REPORTED THE DEVICE STOPPED ABRUPTLY CAUSING THE END-USER TO LOSE POSITIONING AND FALL FORWARD OUT OF THE DEVICE. IT WAS REPORTED THE ENSUING FALL RESULTED IN THE END-USER'S LEGS GETTING STUCK UNDERNEATH THE DEVICE RESULTING IN FRACTURES TO BOTH LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382556 PERMOBIL F3 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization