BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F3

    MDR report key: 8080309 · Received November 16, 2018

    Report

    Report Number
    1221084-2018-00072
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    April 24, 2018
    Report Date
    November 16, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS EQUIPPED WITH A HEAD CONTROL DEVICE ALONG WITH AN ATTENDANT CONTROL MOUNTED ON THE BACKREST. END-USER REPORTED THEY HAD THE BELIEF THAT THE DRIVE CONTROL HAD BEEN TRANSFERRED TO THE ATTENDANT, AND THEY DID NOT CONFIRM VIA THE DISPLAY THAT DRIVE CONTROL WAS SET TO THE OCCUPANT. END-USER REPORTED WHEN THEY PLACED THEIR HEAD AGAINST THE HEADREST, THE CHAIR ACCELERATED FORWARD, STRIKING A PARTITION IN THE VEHICLE WITH THEIR FEET. END-USER STATED IT HAPPENED SO QUICKLY, THEY DIDN'T HAVE TIME TO REACT TO STOP THE FORWARD MOVEMENT. END-USER STATED THEY SUFFERED 2 BROKEN BONES IN THEIR LOWER RIGHT EXTREMITY. DEVICE WAS EVALUATED BY PERMOBIL AND IT WAS FOUND TO BE FULLY FUNCTIONAL WITH NO MALFUNCTIONS NOR DEVIATIONS BEING NOTED. PERMOBIL CONTENDS THE DEVICE DID NOT MALFUNCTION TO HAVE CAUSED THIS ACCIDENT, BUT RATHER THE END-USER DID NOT CONFIRM, VIA THE DISPLAY, AS TO WHICH DRIVE CONTROL WAS IN FOCUS. CLIENT IS VERY FAMILIAR WITH THE CONTROLS AND THIS EVENT WAS AN OVERSITE BY THE END-USER. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    PERMOBIL RECEIVED REPORT FROM END-USER CLAIMING TO HAVE INADVERTENTLY HAVING ENGAGED A DRIVE COMMAND WHICH CAUSED THE CHAIR TO PROPEL FORWARD. REPORTS INDICATE THEY SUFFERED 2 BROKEN BONES IN THEIR LOWER RIGHT EXTREMITY AS THE RESULT OF IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919016 PERMOBIL F3 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization