BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F5 CORPUS VS

    MDR report key: 10265048 · Received July 13, 2020

    Report

    Report Number
    1221084-2020-00033
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    May 8, 2020
    Report Date
    July 13, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K191874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS PROVIDED INDICATE THE EVENT WAS CAUSED BY UNINTENDED ACTIONS MADE BY THE END-USER WHERE THEY INADVERTENTLY DEPRESSED A SEAT FUNCTION BUTTON WHICH INITIATED THE SEATING TO GO INTO A STANDING POSITION. IT WAS REPORTED AT THE TIME OF THIS ACTION OCCURRED, THE END-USER DID NOT HAVE THE NECESSARY SUPPORTS SUCH AS KNEE BLOCK AND CHEST ROLL BAR INSTALLED WHICH ARE REQUIRED TO BE IN PLACE WHENEVER A STAND FUNCTION IS PERFORMED. WITHOUT HAVING ANY SUPPORTS IN PLACE, THE STANDING ACTION ALLOWED THE END-USER TO LOSE THEIR POSITIONING IN THE SEATING AND FALL FORWARD TO THE FLOOR. REPORTS CLAIM THE END-USER'S FEET WERE SECURED TO THE FOOTPLATE WITH STRAPS AND WHEN FALLING FORWARD RESULTED IN THE END-USER SUFFERING A FRACTURE TO THEIR LOWER LEG AND SHIN. THE END-USER CLAIMS THEY HAD GOTTEN THEIR FINGERS CAUGHT BETWEEN THE END OF THE ARMREST AND THE SEAT FUNCTION CONTROL BOX AND INADVERTENTLY ENGAGED THE STAND FUNCTION AND WAS UNABLE TO REMOVE THEIR HAND BEFORE THE RESULTING EVENT OCCURRED. THE DEVICE WAS EVALUATED BY THE LOCAL SERVICE PROVIDER AND WAS FOUND TO BE FULLY OPERATIONAL. PERMOBIL HAS PROVIDED RECOMMENDATIONS OF VARIOUS CONFIGURATION CHANGES THAT COULD BE MADE IN EFFORTS TO MEET THE CLIENTS USE NEEDS, BUT TO MITIGATE ANY CHANCE FOR UNINTENDED ACTIVATION. THE DHR WAS REVIEWED AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTS WHILE END-USER WAS SEATED IN THEIR DEVICE, THEY INADVERTENTLY INITIATED A STAND FUNCTION WITHOUT HAVING ANY OF THE NECESSARY BODY SUPPORTS IN PLACE. THIS ACTION CAUSED THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE SEATING TO THE GROUND RESULTING IN INJURIES REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728530 F5 CORPUS VS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1