BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F5 CORPUS VS

    MDR report key: 11571062 · Received March 25, 2021

    Report

    Report Number
    1221084-2021-00007
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    December 9, 2020
    Report Date
    May 20, 2021
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL EXAMINATION WAS PERFORMED ON THE DEVICE INCLUDING REVIEW OF SYSTEM LOG FOR FAULT CODES. ROOT CAUSE OF THE EVENT CANNOT BE CONFIRMED AS NO MALFUNCTION OF THE DEVICE COULD BE DETECTED, ONLY AN UNUSUAL ADJUSTED STANDING SEQUENCE. PERMOBIL CONTENDS THE MOST PROBABLE ROOT CAUSE, BASED ON THE EVIDENCE COLLECTED, IS THAT THE DEALER FAILED TO FOLLOW THE GIVEN INSTRUCTIONS IN HOW TO PROPERLY ADJUST THE STANDING SEQUENCE TO MEET THAT SPECIFIC END-USER'S NEEDS. AS THE DEVICE WAS FOUND TO HAVE OPERATED AS INTENDED, PRIOR TO THE DEVICE BEING RETURNED TO THE DEALER, A FULL CALIBRATION ON ALL ACTUATORS WAS PERFORMED, FOLLOWED BY A RESET OF STAND FUNCTIONS TO STANDARD FACTORY SETTINGS. PERMOBIL AB HAS REQUESTED THE AREA PERMOBIL REPRESENTATIVE PROVIDE FURTHER EDUCATION TO THE DEALER TECHNICIAN ON THE PROPER SET UP OF STAND SEQUENCE, AND TO ASSIST IN SET UP OF THE DEVICE FOR THE END-USER.

    Additional Manufacturer Narrative · 1

    REPORTS PROVIDED TO PERMOBIL AB CLAIM THE DEALER HAD STARTED TO REUSE AND ADJUST THE WHEELCHAIR FOR A NEW CLIENT. IN THIS PROCESS, THERE WAS A NEED TO READJUST THE SEAT POSITIONING AND STAND FUNCTIONS, THAT SHOULD BE DONE FOR EVERY NEW USER OF THE DEVICE. THE DEALER REPORTEDLY HAD A PROBLEM TO PERFORM THIS PROCESS AND WAS IN CONTACT WITH A PERMOBIL REPRESENTATIVE THAT GUIDED HIM OVER THE PHONE. DESPITE THIS GUIDANCE, THE DEALER WAS REPORTING TO BE UNABLE TO MAKE THE FINAL ADJUSTMENT AND SAVE THE ADJUSTED STANDING PROFILE, AND HE NEEDED LEAVE THE ROOM WHERE THE ADJUSTMENT WAS PERFORMED TO GET FURTHER SUPPORT AND INFORMATION. THE CLIENT WAS STILL REMAINING SITTING IN THE CHAIR AND WHEN THE DEALER RETURNED, THE SEATING UNITS POWER FUNCTIONS HAD MOVED AND THE USER WAS SQUEEZED BY THE SEAT UNIT INTO AN UNFAVORABLE POSITION. REPORTS INDICATE THE DEALER WAS ABLE TO HELP THE CLIENT OUT OF THAT POSITION AND RETURN THE SEATING TO A MORE STABLE POSITION. ONE DAY LATER IT WAS REPORTED THE CLIENT HAD BROKEN THEIR TIBIA DURING THIS INITIAL FITTING PROCESS. THE WHEELCHAIR WAS SENT TO PERMOBIL SERVICE TECHNICIANS IN (B)(6) FOR A INITIAL INSPECTION. THE PRELIMINARY CONCLUSIONS, BASED ON THE INFORMATION PROVIDED BY THE SERVICE TECHNICIAN IN GERMANY, SUGGESTS SOMETHING WENT WRONG IN HOW THE DEALER WAS ADJUSTING THE WHEELCHAIR. IN EFFORT TO DETERMINE A POTENTIAL ROOT CAUSE WITHOUT SPECULATION, THE DEVICE IS BEING RETURNED TO PERMOBIL AB MANUFACTURING HEADQUARTERS FOR A FULL EVALUATION. AT THE TIME OF THIS REPORT, THE EVALUATION HAS NOT BEEN PERFORMED THEREFORE A DETERMINATION CANNOT BE MADE. UPON THE COMPLETION OF THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO INCLUDE PERMOBILS FINDINGS.

    Description of Event or Problem · 1

    PERMOBIL AB RECEIVED REPORT CLAIMING WHILE DEALER WAS PERFORMING AN INITIAL SET UP OF THE STANDING SEATING FUNCTION OF THE DEVICE, THE END-USER ALLEGED THE LEG ANGLE MOVED ON THEIR OWN AND IN DOING SO CAUSED INJURY TO THE END-USER THAT REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463967 F5 CORPUS VS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization