BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS VS

    MDR report key: 18876623 · Received March 11, 2024

    Report

    Report Number
    1221084-2024-00004
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    January 28, 2024
    Report Date
    March 11, 2024
    Manufacturer
    PERMOBIL AB
    Product Code
    IPL
    PMA / PMN Number
    K191874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE END-USER CLAIMS AS THEY WERE OPERATING THEIR DEVICE, THE DEVICE REPORTEDLY STARTED DRIVING BY ITSELF AND THE END-USER DID NOT HAVE THE ABILITY TO STOP OR COURSE CORRECT VIA THE JOYSTICK CONTROLLER. THIS ACTION REPORTEDLY FORCED THE DEVICE TO COLLIDE INTO A RAILROAD TRACK BED, RESULTING WITH THE END-USER BEING EJECTED FROM THE SEATING AND SUSTAINING INJURIES REQUIRING MEDICAL INTERVENTION. REPORTS INDICATE THE END-USER SUSTAINED BROKEN RIBS AS A RESULT OF THE FALL. INTERVIEWS WITH THE END-USER WERE LIMITED DUE TO THE END-USER REPORTING HAVING NO MEMORY OF THE EVENT. DEVICE WAS RETURNED TO PERMOBIL GERMANY FOR INSPECTION. REPORTS INDICATE THE DEVICE WAS RECEIVED IN AN INOPERABLE STATE, WITH SIGNS OF PHYSICAL DAMAGES. PERMOBIL WAS UNABLE TO DISCERN IF THE NOTED DAMAGES WHERE THE RESULT OF THE EVENT, OR HAD BEEN INFLICTED PRIOR TO THE EVENT OVER THE COURSE OF THE DEVICES 7 YEARS OF USE. PERMOBIL WAS UNABLE TO CONFIRM THE REPORTED MALFUNCTION OF "UNINTENDED MOVEMENT" DUE TO THE CONDITION OF THE DEVICE UPON RECEIPT. PERMOBIL GERMANY WILL CONTINUE TO INVESTIGATE, AND IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING WHILE THE END-USER WAS OPERATING THEIR WHEELCHAIR OUT-OF-DOORS, REPORTED THAT THE WHEELCHAIR STARTED DRIVING ON ITS OWN CAUSING THE END-USER TO LOSE CONTROL. THIS SUDDEN START REPORTEDLY CAUSED THEM TO CRASH INTO A TRACK BED RESULTING IN INJURIES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968036 PERMOBIL F5 CORPUS VS POWERED WHEELCHAIR IPL PERMOBIL AB F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization