BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS VS

    MDR report key: 17062850 · Received June 5, 2023

    Report

    Report Number
    1221084-2023-00010
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 8, 2023
    Report Date
    August 15, 2023
    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

    PHOTOS PROVIDED OF THE DEVICE AFTER THE INCIDENT SHOW THE SEATING PORTION OF THE WHEELCHAIR HAVING BEEN RAISED AND TILTED FORWARD, WITH THE BACK REST ANGLE HAVING REMAINED AT APPROXIMATELY 90° TO THE SEATING. THIS POSITION WAS REPORTED TO HAVE FORCED THE END-USER TO LOSE POSITIONING AND FALL FORWARD OUT OF THE SEATING WHERE THEY REPORTED HAVING SUSTAINED BROKEN BONES IN THEIR FOOT. AT THE TIME OF THIS REPORT, PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO THE POSSIBLE ROOT CAUSE OF THE REPORTED MALFUNCTION. THE SUSPECT DEVICE IS TO BE RETURNED TO PERMOBIL AB FOR EVALUATION. UPON COMPLETION OF INSPECTION/EVALUATION OF THE DEVICE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    PERMOBIL AB IN SWEDEN RECEIVED THE SUSPECT ACTUATOR IN A PHYSICALLY DAMAGED STATE. UPON TESTING, IT WAS CONFIRMED TO BE OPERATING ABNORMALLY WHERE WHEN CONNECTED TO A POWER SOURCE, THE ACTUATOR WOULD IMMEDIATELY BE ACTIVE WITHOUT A SIGNAL SOURCE. THE SUSPECT COMPONENT WAS RETURNED TO THE SUPPLIER MANUFACTURER, LINAK, FOR FURTHER EVALUATION. SUPPLIER ALSO CONFIRMED FAILURE, AND THROUGH TESTING DETERMINED A LOGIC COMPONENT ON THE PCB OF THE ACTUATOR WAS CRACKED, CAUSING A SHORT ON THE PCB. ONCE THE LOGIC COMPONENT WAS REPLACED, THE ACTUATOR OPERATED AND FUNCTIONED AS EXPECTED. IT WAS DETERMINED BY THE SUPPLIER THAT THE FAILURE WAS DUE TO EXTERNAL DAMAGE TO THE HOUSING WHICH LED TO THE SHORT CIRCUIT OF THE PCB COMPONENT. ALTHOUGH IT WAS CONFIRMED THAT PHYSICAL DAMAGES TO THE ACTUATOR WAS THE ROOT CAUSE OF THE FAILURE, PERMOBIL AB CANNOT REACH A DETERMINATION AS TO IF THE DEVICE WAS USED OUTSIDE OF ITS INTENDED USE, THEREFORE ARE UNABLE TO DETERMINE A ROOT-CAUSE WITHOUT SPECULATION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING THE END-USER WAS USING THEIR STOVE WHEN THE WHEELCHAIR SEATING STARTED TILTING FORWARD WITHOUT USER INPUT. EACH TIME THEY POWERED THE WHEELCHAIR ON, THE SEATING CONTINUED TO TILT FORWARD, FORCING THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE SEATING TO WHERE THEY SUSTAINED AN INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675216 PERMOBIL F5 CORPUS VS POWERED WHEELCHAIR IPL PERMOBIL AB F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization