BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M5

    MDR report key: 10677469 · Received October 14, 2020

    Report

    Report Number
    1221084-2020-00049
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    August 24, 2020
    Report Date
    December 11, 2020
    Manufacturer
    PERMOBIL AB (PAB
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL TECHNICIANS EVALUATED THE SUSPECT SEAT TILT IN ATTEMPTS TO RECREATE THE REPORTED MALFUNCTION WITHOUT SUCCESS. HOWEVER, WHEN THE SEAT TILT IS WEIGHTED TO 330LBS, ABOVE THE MAXIMUM USER WEIGHT LIMIT (300LBS), IT WAS POSSIBLE TO SEE A SLIGHT CHANGE IN POSITION OF THE SEAT UNIT. AFTER FURTHER CONVERSATION WITH THE USER, IS IT NO LONGER OBVIOUS THAT THE SEAT UNIT LOWERED ITSELF FROM THE HORIZONTAL POSITION (0 DEGREES) AS INITIALLY REPORTED. THE WHEELCHAIR WAS DISTRIBUTED WITH LEG REST EXTENSIONS AND THE SEAT POSITION MUST BE ADJUSTED BEFORE CLIMBING OBSTACLES OR DRIVING ON UNEVEN SURFACES OR SLOPES ACCORDING TO THE USER MANUAL. THE USER WAS INSTRUCTED BY PERMOBIL, WHEN THE WHEELCHAIR WAS DELIVERED, TO MAKE APPROPRIATE SEAT ADJUSTMENTS TO ALLOW FOR THE REQUIRED GROUND CLEARANCE TO AVOID UNWANTED IMPACT WHEN DRIVING OUTDOORS. THIS ADDITIONAL LEG LENGTH REQUIREMENT FOR THE USER CHANGES THE GROUND CLEARANCE CAPABILITY COMPARED TO A STANDARD CONFIGURATION. THE INSTRUCTIONS FOR INTENDED USE WERE DISREGARDED AT THE POINT OF THE INCIDENT, AS THE USER ALLOWED THEY PREFER TO SIT IN A MORE ANTERIOR POSITION WHILE OPERATING THE WHEELCHAIR. IN CONCLUSION TO THE FINDINGS IN OUR INVESTIGATION, THE LEG REST ASSEMBLY HIT AN OBSTACLE IN THE USER'S DRIVEWAY AND THAT CAUSED THE CHAIR TO RAPIDLY STOP. THEREFORE, ROOT CAUSE IS BEING ATTRIBUTED TO INADVERTENT ERROR OF THE END-USER.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTS CLAIM AS THE END-USER COMPLETED THE OPERATION OF RETURNING THE SEATING TO A LEVEL PLANE VIA THE TILT FUNCTION, IT WAS ALLEGED THE SEATING CONTINUED TO SLOWLY LOWER PAST THE HORIZONTAL PLANE ALLOWING THE FOOTPLATES TO CONTACT THE GROUND. WITH THE END-USER DRIVING AT SPEED, THE CONTACT WITH THE GROUND CAUSED THE DEVICE TO LOSE ITS FORWARD MOMENTUM, STOPPING SUDDENLY. IT WAS REPORTED THIS SUDDEN STOPPAGE CAUSED THE END-USER TO LOSE THEIR POSITIONING AND TO FALL TO THE GROUND WHERE THEY SUSTAINED A FRACTURE TO THEIR LEG. AT THIS TIME, PERMOBIL IS UNABLE TO CONFIRM A COMPONENT FAILURE HAVING OCCURRED AS ALLEGED. THE DEVICE IS REPORTED TO REMAIN OPERATIONAL AND IS CONTINUED TO BE IN USE BY THE END-USER FOR THEIR DAILY ACTIVITIES. PERMOBIL, AS WELL AS SERVICE PROVIDER, HAVE GIVEN INSTRUCTION TO THE END-USER TO REFRAIN FROM OPERATING THE ELEVATE/TILT FUNCTIONS UNTIL THE SUSPECT COMPONENT CAN BE REPLACED WITH NEW. THE SUSPECT COMPONENT (AP ASSEMBLY) FROM THE INCIDENT WILL BE SENT TO PERMOBIL AB FOR INSPECTION/EVALUATION. UPON RECEIPT OF ANY NEW INFORMATION, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING WHILE THE END-USER WAS DRIVING AT SPEED, THEY WERE SIMULTANEOUSLY LOWERING THE SEATING FROM A POSTERIOR TILTED POSITION. IT WAS ALLEGED THE SEATING TRAVELED FARTHER THAN ANTICIPATED WHICH ALLOWED THE LEG REST TO CONTACT THE GROUND THAT CAUSED THE DEVICE TO SUDDENLY STOP. REPORTS CLAIM THE SUDDEN STOP CAUSED THE END-USER TO LOSE POSITIONING AND TO FALL OUT OF THE SEATING TO THE GROUND RESULTING IN AN INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143162 PERMOBIL M5 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB M5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization