BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F3

    MDR report key: 10540298 · Received September 16, 2020

    Report

    Report Number
    1221084-2020-00046
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    March 1, 2020
    Report Date
    November 16, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE PROVIDER EVALUATED THE DEVICE AND REPORTED THE ALTERNATIVE DRIVE CONTROL, MINI JOYSTICK, WAS FOUND TO BE NON-OPERATIONAL. THE COMPONENT WAS REPLACED WITH NEW, DEVICE OPERATIONALLY TESTED SATISFACTORY AND RETURNED TO THE END-USER. THE AFFECTED MINI JOYSTICK ASSEMBLY WAS SENT TO PERMOBIL AB FOR EVALUATION. RESULTS CONCLUDED A FAILURE HAVING OCCURRED WITH A COMPONENT ON THE INTERNAL PRINTED CIRCUIT BOARD (PCB) OF THE MINI JOYSTICK MODULE WHICH PREVENTED A DRIVE SIGNAL FROM REACHING THE MAIN CONTROL UNIT (POWER MODULE). WHEN THE COMMUNICATION IS PROHIBITED BETWEEN THESE MODULES, THE WHEELCHAIR WILL BE STOPPED FROM ALLOWING DRIVE. THERE ISN'T ANY SUPPORTING EVIDENCE TO CONCLUDE WHY THE COMPONENT FAILURE ON THE PCB OCCURRED, THUS ACTUAL ROOT CAUSE CANNOT BE DETERMINED. AS A CONTRIBUTING FACTOR, IT WAS REPORTED THE END-USER WAS NOT WEARING THEIR POSITIONING BELT AS OUTLINED IN THE USER MANUAL.

    Additional Manufacturer Narrative · 1

    INFORMATION PROVIDED INDICATES THE REPORTED INCIDENT OCCURRED APPROXIMATELY 6 MONTHS PRIOR WHILE THE END-USER WAS RESIDING IN (B)(6). REPORTS CLAIM THE END-USER SUSTAINED A CONCUSSION AS A RESULT OF THE FALL AND HAS SINCE RECOVERED FROM THEIR INJURY. SINCE THE EVENT OCCURRENCE, THE END-USER HAS RELOCATED BACK TO SWEDEN TO WHEN THE EVENT WAS REPORTED TO THEIR LOCAL PROVIDER. INFORMATION PROVIDED CLAIMED THE DEVICE WAS EVALUATED, AND REPORTED AS HAVING BEEN REPAIRED AND RETURNED BACK TO THE END-USER. THIS EVALUATION AND SERVICE OCCURRED PRIOR TO PERMOBIL AB BEING NOTIFIED OF THE EVENT OCCURRENCE. DESPITE MULTIPLE ATTEMPTS TO GATHER INFORMATION FROM THE SERVICE PROVIDER, PERMOBIL HAS BEEN UNABLE TO RECEIVE ANY INFORMATION AS TO THE FINDINGS FROM THE SERVICE EVALUATION, OR WHAT REPAIRS WERE CONDUCTED. WITH THE LACK OF INFORMATION PROVIDED, PERMOBIL IS UNABLE TO ESTABLISH A POSSIBLE CAUSE OF THE REPORTED EVENT AT THIS TIME. PERMOBIL AB WILL CONTINUE IN THEIR EFFORTS TO OBTAIN FURTHER INFORMATION, AND IF UPON RECEIPT OF ANY NEW INFORMATION, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS END-USER WAS DRIVING THEIR POWER WHEELCHAIR DOWN A HILL, THE DEVICE WAS REPORTED TO HAVE SUDDENLY STOPPED, CAUSING THE END-USER TO LOSE THEIR POSITIONING AND FALL OUT OF THE SEATING TO THE GROUND. REPORTS INDICATE THE END-USER RECEIVED INJURIES REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008224 PERMOBIL F3 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization