BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS VS

    MDR report key: 18381488 · Received December 22, 2023

    Report

    Report Number
    1221084-2023-00025
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    November 24, 2023
    Report Date
    April 2, 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 DEVICE WAS RETURNED TO THE PERMOBI LAB WHERE THE WHEELCHAIR AND ITS PROGRAMMING WERE INSPECTED MULTIPLE TIMES WITH THE DEVICE BEING FOUND TO REMAIN FULLY OPERATIONAL WITH NO SIGNS OF A MALFUNCTION HAVING OCCURRED. SUSPECT COMPONENTS WERE PROVIDED TO THE RESPECTIVE SUPPLIERS FOR A MORE IN-DEPTH EVALUATION, WITH EACH SUPPLIER REPORTING FINDING THE RESPECTIVE COMPONENTS AS BEING FULLY OPERATIONAL WITH NO NOTABLE DEVIATIONS BEING FOUND. ALTHOUGH THERE WERE SOME SIGNS OF PHYSICAL DAMAGES TO THE DEVICE AND SOME OF THE CABLING. IT WAS DETERMINED THAT NONE OF THESE DAMAGES WOULD HAVE CONTRIBUTED TO THE EVENT AS DESCRIBED HAVING OCCURRED. AFTER COMPLETION OF EVALUATION, PERMOBIL AB WAS UNABLE TO CONFIRM A FAILURE HAVING OCCURRED, THUS IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE WITHOUT A DEGREE OF SPECULATION.

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED THUS FAR FROM PERMOBIL AB INDICATES THE WHEELCHAIR WAS RETURNED TO THE DISTRIBUTOR, AND PERMOBIL AB ARE PLANNING FOR THE DEVICE TO BE INSPECTED AND EVALUATED FOR POSSIBLE CAUSE OF THE REPORTED EVENT. CURRENTLY THERE IS NO INFORMATION BESIDES THE INCIDENT DESCRIPTION AVAILABLE. AS 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 DRIVING THE WHEELCHAIR, THE LEG REST FUNCTION BEGAN TO ELEVATE WITHOUT INPUT FROM THE END-USER. THE REPORT INDICATES THE KNEE BLOCK ASSEMBLY WAS INSTALLED AND WHEN RAISING, APPLIED EXCESSIVE PRESSURE TO THE END-USER'S LEGS RESULTING IN INJURIES REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298727 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