BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C300

    MDR report key: 6171598 · Received December 13, 2016

    Report

    Report Number
    1221084-2016-00052
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 13, 2016
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL (B)(4) RECEIVED CALL FROM END-USER REPORTING AS THEY WERE DRIVING AT SPEED, THE CHAIR STOPPED SUDDENLY, WITHOUT WARNING, THRUSTING THE END-USER FORWARD IN THE SEATING DUE TO MOMENTUM. WHEN THIS OCCURRED, THE END-USER FRACTURED THEIR LEFT FEMUR. IT IS BELIEVED THE FRACTURE WAS THE RESULT OF THE END-USERS PRE-EXISTING CONDITION OF OI, WHILE BEING RESTRAINED IN THE SEATING VIA A POSITIONING BELT, CAUSED THE FEMUR TO FRACTURE DUE TO STRESS. AN INSPECTION OF THE CHAIR WAS PERFORMED AND IT WAS FOUND THAT A CIRCUIT BOARD RESPONSIBLE FOR DRIVE CONTROL COMMUNICATION HAD BECOME LOOSE FROM ITS MOUNTING POINT. WITH THIS LOSS OF CONNECTION, THE ELECTRONICS SENSED THE SIGNAL LOSS AND AS PER DESIGN, BROUGHT THE CHAIR TO A CONTROLLED STOP. THERE WAS NOT AN INTERRUPTION IN POWER, BUT RATHER A RAPID CONTROLLED STOP. UPON RE-SEATING OF THE CIRCUIT BOARD, UNIT WAS OP-TESTED WITH NO FURTHER ISSUES BEING NOTED. IT IS UNCLEAR AS TO THE CAUSE OF THE CIRCUIT BOARD TO HAVE BECOME LOOSE AS THIS IS NOT A KNOWN REPORTED EVENT. IT IS PRESUMED THAT VIBRATION OF THE CHASSIS DUE TO VARIANCES IN TERRAIN, OVER TIME, CAUSED THE LOOSENING ON THE SETTING OF THE BOARD TO ITS MOUNTING POINT. THE DHR WAS REVIEWED AND UNIT WAS FOUND TO HAVE BEEN BUILT ACCORDING TO SPECIFICATION. INSPECTED BY PERMOBIL REPRESENTATIVE.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT AS END-USER WAS DRIVING AT SPEED, THE UNIT ALLEGEDLY SHUT DOWN STOPPING SUDDENLY. REPORTS ARE END-USER SUFFERED A BROKEN LEFT FEMUR AS RESULT OF THIS EVENT. ACCOUNTS ARE END-USER WAS TRAVERSING THROUGH A TRAIN STATION TRAVELING AT APPROXIMATELY 9KM/H WHEN THE CHAIR REPORTEDLY LOST POWER CAUSING THE UNIT TO STOP ABRUPTLY. REPORTS ARE END-USER WAS WEARING A POSITIONING BELT WHEN THIS INCIDENT OCCURED AND REMAINED SECURED IN THE SEATING. IT IS BELIEVED THE INJURY WAS CAUSED WHEN THE UNIT ALLEGEDLY STOPPED, QUICKLY THRUSTING THE END-USERS BODY FORWARD DUE TO MOMENTUM. WITH THE END-USER BEING SECURED TO SEATING VIA THE POSITIONING BELT, COMBINED WITH HER PRE-EXISTING DIAGNOSIS, CAUSED THE FEMUR BONE TO FRACTURE DUE TO STRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821353 PERMOBIL C300 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization