BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F5 CORPUS VS

    MDR report key: 11603515 · Received April 1, 2021

    Report

    Report Number
    1221084-2021-00010
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 1, 2021
    Report Date
    June 9, 2021
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K191874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CO-PILOT ATTENDANT CONTROL WAS REPLACED WITH A NEW UNIT WHILE SUSPECT CONTROL WAS SENT TO PERMOBIL AB FOR ANALYSIS. THE WHEELCHAIR HAS BEEN RETURNED TO THE END-USER WITH NO FURTHER ISSUES BEING REPORTED. THE SUSPECTED AFFECTED COMPONENT, CO-PILOT ATTENDANT CONTROL, WAS RETURNED TO PERMOBIL AB FOR INSPECTION AND FUNCTIONAL TESTING. NO VISUAL DAMAGES WERE NOTED, AND ALL SENSORS WERE FOUND TO BE PROPERLY POSITIONED AND FULLY FUNCTIONAL DURING OPERATIONAL TESTING. RESPONSE FROM THE UNIT DURING TEST DRIVE WAS AS PER INTENDED DESIGN WITH INSTALLED SAFETY MEASURES (DEAD MANS GRIP) WORKING AS INTENDED. PERMOBIL AB WAS UNABLE TO CONCLUDE A MALFUNCTION HAD OCCURRED WITH THE CO-PILOT CONTROL. PERMOBIL HAS DETERMINED THE PROBABLE CAUSE OF THE REPORT OF UNINTENDED MOVEMENT WAS USE ERROR IN NOT FOLLOWING OPERATIONAL INSTRUCTIONS THAT WERE PROVIDED IN THE USER MANUAL AND WARNING LABELING ON THE DEVICE COMPONENT.

    Additional Manufacturer Narrative · 1

    PRELIMINARY REPORTS INDICATE THIS SPECIFIC WHEELCHAIR IS EQUIPPED WITH 2 DIFFERENT STEERING DEVICES AND BOTH ARE ATTACHED TO THE BACKREST OF THE WHEELCHAIR TO BE USED AS ATTENDANT CONTROLS BY A CAREGIVER. WHEN THE INCIDENT OCCURRED, IT WAS REPORTED THE CAREGIVER ATTEMPTED TO MOVE THE WHEELCHAIR FORWARD BY ONE OF THE STEERING DEVICES (THE CO-PILOT), THE WHEELCHAIR MOVED IN THE OPPOSITE REVERSE DIRECTION. THIS REPORTEDLY CAUGHT THE CAREGIVER OFF GUARD WHICH CAUSED THEM TO STRAIN THEIR WRIST. THE SERVICE PROVIDER REQUESTED PERMOBIL TO INSPECT THE DEVICE AND IN EFFORT TO DETERMINE A POTENTIAL ROOT CAUSE, THE SUSPECT CO-PILOT CONTROL 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 PERMOBIL'S FINDINGS.

    Description of Event or Problem · 1

    PERMOBIL AB RECEIVED REPORT CLAIMING WHILE THE CAREGIVER WAS ATTEMPTING TO MOVE THE DEVICE IN A FORWARD DIRECTION VIA THE CO-PILOT ATTENDANT CONTROL, THE DEVICE ALLEGEDLY OPERATED IN THE OPPOSITE DIRECTION THAN WAS EXPECTED. THIS UNEXPECTED ACTION REPORTEDLY CAUSED THE CAREGIVER TO STRAIN THEIR WRIST. NO MEDICAL INTERVENTION WAS SOUGHT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500884 F5 CORPUS VS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1