BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS

    MDR report key: 17272970 · Received July 6, 2023

    Report

    Report Number
    1221084-2023-00012
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 6, 2023
    Report Date
    February 20, 2024
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT INDICATES THE WHEELCHAIR IS EQUIPPED WITH TWO JOYSTICK CONTROL PANELS: ONE ON THE LEFT AND ONE ON THE RIGHT ARMREST. REPORT CLAIMS THE INCIDENT OCCURRED WHEN THE END-USER TURNED ON THE WHEELCHAIR WITH THE LEFT PANEL BUT GOT THE WHEELCHAIR MOVING BY PRESSING THE JOYSTICK ON THE RIGHT PANEL. IT TOOK SOME TIME TO STOP THE WHEELCHAIR AS THE USER WAS NOT PREPARED FOR THIS TO HAPPEN. REPORT CLAIMS THE INCIDENT HAPPENED SO QUICKLY THAT IT FORCED THE USER TO STRIKE AN IMMOVABLE OBJECT WITH THEIR FEET WHICH RESULTED IN A FRACTURED BONE IN THEIR LEFT FOOT, AND A BROKEN TOE ON EACH FOOT. REVIEW OF THE CLIENT FILE INDICATES THE DEVICE SHIPPED IN NOVEMBER 2016 WITH ONE CONTROL PANEL INSTALLED ON LEFT ARMREST. IT IS UNKNOWN TO PERMOBIL AB AS TO WHEN THE ADDITIONAL CONTROL PANEL WAS INSTALLED, AND/OR BY WHOM. DEPENDING ON HOW THE DEVICE IS CONFIGURED, IT IS POSSIBLE TO CONFIGURE THE DEVICE TO BE DEPENDENT ON THE CONTROL PANEL THAT IS USED TO POWER UP THE DEVICE TO BE THE PRIMARY (IN FOCUS) CONTROL PANEL. IT IS ALSO AVAILABLE THAT THE ELECTRONICS BE SET UP TO HAVE "LAST USED" BE THE CONTROL IN FOCUS, MEANING THE JOYSTICK THAT WAS IN OPERATION WHEN THE CHAIR WAS LAST USED WILL BE THE ONE THAT IS USEABLE WHEN THE DEVICE IS POWERED UP AGAIN, REGARDLESS OF THE SOURCE. AT THIS TIME THE DEVICE HAS YET TO BE EVALUATED TO DETERMINE A POSSIBLE CAUSE FOR THIS EVENT. WHEN PERMOBIL AB RECEIVES ANY NEW INFORMATION AS TO PROBABLE CAUSE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    A PERMOBIL TECHNICIAN CONTROLLED THE WHEELCHAIR AND ITS PROGRAMMING AND FOUND NO PROBLEMS. THE WHEELCHAIR WAS CONFIGURED IN A WAY THAT LIMITED THE CONTROL OF THE WHEELCHAIR TO THE JOYSTICK CONTROL PANEL THAT WAS USED TO POWER ON THE WHEELCHAIR WHILE STILL ALLOWING BOTH JOYSTICKS CONTROL PANELS TO TURN THE WHEELCHAIR OFF. THE CORRECT FUNCTION OF THIS WAS ENSURED BY TESTING IT MULTIPLE TIMES. DURING THE CONTROL AND INVESTIGATION IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED PROBLEM. IT IS HYPOTHISIZED THAT THE INCIDENT WAS CAUSED BY A USE ERROR, POSSIBLY THE WHEELCHAIR WAS NOT TURNED OFF WHEN SWITCHING FROM THE RIGHT PANEL TO THE LEFT PANEL, KEEPING THE RIGHT PANEL ACTIVE AND IN CONTROL, BUT THIS IS SPECULATIVE. IT IS UNKNOWN WHY THE USER WAS NOT ABLE TO TURN THE WHEELCHAIR OFF WITH THE RIGHT PANEL AS ALLEGED. NO MECHANICAL, ELECTRICAL, OR PROGRAMMING ISSUED WERE FOUND.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING THE POWER WHEELCHAIR IS CURRENTLY EQUIPPED WITH 2 JOYSTICKS AT THE END OF EACH ARM REST. REPORT INDICATES THE END-USER POWERED UP THE DEVICE USING THE LEFT JOYSTICK, AND CLAIMS THE DEVICE SUDDENLY MOVED WHEN THE END-USER HIT THE RIGHT JOYSTICK WITH THEIR HAND. THIS REPORTED INVOLUNTARY MOVEMENT CAUSED THE END-USER TO STRIKE AN IMMOVEABLE OBJECT RESULTING IN AN INJURY TO THEIR FOOT REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031585 PERMOBIL F5 CORPUS POWERED WHEELCHAIR ITI PERMOBIL AB F5 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization