BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C500

    MDR report key: 10291273 · Received July 17, 2020

    Report

    Report Number
    1221084-2020-00034
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 17, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS RECEIVED BY PERMOBIL BELGIUM CLAIM WHILE THE END-USER WAS DRIVING THEIR DEVICE DOWN A SIDEWALK AT SPEED, THE DEVICE SUDDENLY STOPPED CAUSING THE END-USER TO LOSE THEIR POSITIONING AND FALL OUT OF THE SEATING TO THE GROUND. REPORTS INDICATE THE FALL RESULTED IN JURIES CONSISTING OF FRACTURED TEETH AND LACERATION TO THE CHIN REQUIRING STITCHES. INSPECTION OF THE DEVICE WAS PERFORMED BY PERMOBIL TECHNICIANS WHERE FINDINGS SHOWN DAMAGES TO ONE OF THE ELECTRICAL CABLES FOR THE RIGHT MOTOR BRAKE. THIS DAMAGE WOULD CAUSE AN OPEN CIRCUIT WHICH RESULTS IN LOSS OF CONTINUITY, INTERRUPTING THE POWER TO THE ELECTRIC BRAKE. THIS LOSS OF POWER TO THE BRAKE, IF IT WERE TO RECUR WHILE DRIVING, WOULD CAUSE THE MOTOR/GEARBOX TO STOP ROTATING. THIS WOULD EXPLAIN THE SUDDEN STOP AS DESCRIBED BY THE END-USER. INSPECTION SHOWN A PLASTIC END-CAP WHICH ATTACHES TO THE END OF THE UNITRACK SEAT RAIL HAVING FALLEN OFF AND BECOME WEDGED BETWEEN THE MOTOR/BRAKE AND CHASSIS. IT IS UNCLEAR AS TO HOW LONG THIS END CAP HAD BEEN IN THIS POSITION, BUT EVALUATION RESULTS SHOWN THIS WEDGED COMPONENT HAVING DAMAGED ONE OF THE POWER WIRES LEADING TO THE RIGHT BRAKE SOLENOID. REVIEW OF COMPLAINT DATA INDICATES THIS TO BE AN ISOLATED EVENT WITH NO RECORDS TO INDICATE THIS FAILURE MODE HAVING BEEN PREVIOUSLY REPORTED. IT WAS NOTED THAT THE POSITIONING BELT WHICH WAS PROVIDED WHEN DEVICE WAS ORIGINALLY DISTRIBUTED HAD BEEN REMOVED AT SOME POINT SINCE DISTRIBUTION AND WAS NOT BEING USED AT THE TIME OF THE INCIDENT. DEVICE REMAINS AT PERMOBIL BELGIUM'S SERVICE CENTER UNTIL A DETERMINATION IS MADE BETWEEN HEALTHCARE FACILITY, INSURANCE PROVIDER AND END USER AS TO IF THIS 4 YEAR OLD DEVICE WILL BE REPAIRED OR REPLACED. THE DHR WAS REVIEWED AND THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING WHILE WAS USER WAS DRIVING BESIDES HIS SON WHO WAS ON HIS BIKE. USER WAS DRIVING MAXIMUM SPEED (10 KM/U) WHEN SUDDENLY THE DRIVE MOTOR STOPPED. REPORTS CLAIM END-USER LOST POSITIONING ALLOWING THEM TO FALL OUT OF THE SEATING TO THE GROUND RESULTING IN INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754922 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization