BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F3 CORPUS

    MDR report key: 17614287 · Received August 24, 2023

    Report

    Report Number
    1221084-2023-00015
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    July 2, 2023
    Report Date
    August 24, 2023
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB REPORTS THE DEALER SERVICE TECHNICIAN EVALUATED THE WHEELCHAIR AND FOUND A LOOSE CABLE CONNECTION IN THE R-NET ELECTRONICS SYSTEM. TECHNICIAN REPORTS HAVING CHECKED ALL REMAINING CABLE CONNECTIONS, CONFIRMING ALL WERE CORRECTLY SECURED AND VERIFIED THROUGH OPERATIONAL TESTING WITH NO FURTHER ISSUES BEING FOUND. 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 THE END-USER WAS OUT DRIVING WHEN THE CHAIR STOPPED, AND A BAD CABLE ERROR CODE CAME UP ON THE MAJIC DRIVE TOUCH DISPLAY. AFTER A WHILE THE CHAIR STARTED WORKING AGAIN AND THE USER COULD DRIVE. WHILE THEY WERE DRIVING HOME TO GET A CHECK ON THE CHAIR, JUST BEFORE REACHING THEIR HOUSE, THE CHAIR ABRUPTLY STOPPED AGAIN. THE SUDDEN STOP REPORTEDLY CAUSED THE END-USER TO LOSE POSITIONING AND FALL FROM THE SEATING WHERE THEY SUSTAINED INJURIES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202089 PERMOBIL F3 CORPUS POWERED WHEELCHAIR ITI PERMOBIL AB F3 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization