BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL F3

    MDR report key: 11964568 · Received June 9, 2021

    Report

    Report Number
    1221084-2021-00021
    Event Type
    Death
    Date Received
    June 9, 2021
    Date of Event
    March 26, 2021
    Report Date
    June 9, 2021
    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

    INVESTIGATION PERFORMED BY PERMOBIL (B)(4) CONCLUDED THE WHEELCHAIR DID NOT MALFUNCTION AND WAS OPERATING AS INTENDED BOTH BEFORE AND DURING THE TRANSPORT OF THE WHEELCHAIR ON THE STAIRWAY LIFT. INSPECTION OF THE DEVICE COULD NOT IDENTIFY A PRODUCT MALFUNCTION HAVING OCCURRED, NOR COULD A TECHNICAL ROOT CAUSE OR MALFUNCTION BE LINKED TO THE WHEELCHAIR. PERMOBIL HAS DETERMINED ONE OF THE CONTRIBUTING ROOT CAUSES AS BEING ATTRIBUTED TO USER ERROR IN THE WAY THE USER WAS HANDLING THE WHEELCHAIR DURING TRANSPORT ON THE PLATFORM. PERMOBIL HAS RECOMMENDED THAT THE PLATFORM LIFT BE INSPECTED TO VERIFY SAFETY PROTOCOLS WERE IN PLACE AND FUNCTIONAL AT THE TIME OF EVENT. PERMOBIL HAS NO INFORMATION AS TO THE MAKE/ MODEL OF THE LIFT OR WHAT SAFETY PARAMETERS ARE INCORPORATED AS PART OF ITS DESIGN. PERMOBIL CANNOT TAKE ANY FURTHER ACTION AS THE WHEELCHAIR WAS FOUND TO BE OPERATING AS PER DESIGN. THE DHR WAS REVIEWED, AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    PERMOBIL (B)(4) RECEIVED REPORT INDICATING THE END-USER WAS UTILIZING STAIR LIFT TO TRAVERSE UP THE STAIRS IN THEIR HOME WHILE REMAINING SEATED IN THE PERMOBIL WHEELCHAIR. UPON REACHING THE TOP OF THE STAIRS, WHEN ATTEMPTING TO EXIT THE PLATFORM, THE END-USER INADVERTENTLY DROVE IN REVERSE CAUSING THE WHEELCHAIR, WITH THE END-USER, TO FALL DOWN THE STAIRS TO THE GROUND FLOOR. REPORTS INDICATE THE END-USER WAS TRANSPORTED TO THE AREA HOSPITAL WHERE THEY SUBSEQUENTLY SUCCUMBED TO THEIR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860344 PERMOBIL F3 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death