BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C300 CORPUS

    MDR report key: 16771152 · Received April 19, 2023

    Report

    Report Number
    1221084-2023-00008
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 19, 2023
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED CLAIMS AS A CAREGIVER WAS ASSISTING IN TRANSFERRING THE END-USER FROM POWER WHEELCHAIR TO THEIR BED, THE CAREGIVER INADVERTENTLY CONTACTED THE JOYSTICK KNOB WITH THEIR BODY. THIS REPORTEDLY CAUSED THE DEVICE TO INITIATE A DRIVE COMMAND, FORCING THE WHEELCHAIR INTO THE BED FRAME RESULTING IN THE END-USER SUSTAINING A FRACTURED TIBIA. SERVICE PROVIDER REPORTS HAVING INSPECTED THE DEVICE AND FOUND IT TO REMAIN FULLY OPERATIONAL WITH NO NOTABLE ISSUES. WITH TESTIMONY FROM THE END-USER CLAIMING AN OVERSIGHT OF LEAVING THE DEVICE POWERED ON DURING A TRANSFER, IT IS PERMOBIL'S DETERMINATION THIS EVENT WAS CAUSED BY INADVERTENT USE ERROR. THE END-USER WAS RE-EDUCATED TO THE WARNINGS IN PERMOBIL C300 USE MANUAL WHERE IT IS OUTLINED THE WHEELCHAIR NEEDS TO BE TURNED OFF WHEN MOVING IN OR OUT OF THE SEATING. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB, IN SWEDEN, RECEVIED A REPORT CLAIMING AS A CAREGIVER WAS ATTEMPTING TO TRANSFER THE END-USER FROM THE POWER WHEELCHAIR TO THE BED. THE JOYSTICK WAS HIT BY THE CAREGIVER WHICH CAUSED THE WHEELCHAIR TO MOVE AND COLLIDE INTO THE SIDE OF THE BED. THIS ACTION REPORTEDLY RESULTED IN AN INJURY TO THE END-USER REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937366 PERMOBIL C300 CORPUS POWERED WHEELCHAIR ITI PERMOBIL AB C300 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization