BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F3

    MDR report key: 6487835 · Received April 12, 2017

    Report

    Report Number
    1221084-2017-00015
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    February 10, 2017
    Report Date
    April 12, 2017
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS INSPECTED BY PERMOBIL AREA SALES MANAGER ALONG SIDE WITH THE SERVICE PROVIDER TERRITORY SERVICE MANAGER. DURING THE INSPECTION, THE UNIT WAS REPORTED TO HAVE BEEN DRIVEN BOTH FORWARDS AND REVERSE, AT VARIOUS SPEEDS WITHOUT ANY ISSUES HAVING BEEN NOTED. REVIEW OF THE UNITS SYSTEM LOGS DID NOT SHOW HISTORY OF AN ERROR TO HAVE BEEN TRIPPED IN RELATION TO THE DRIVE MOTORS OR ANY ELECTRICAL OR SOFTWARE ISSUES HAVING OCCURED THAT MAY HAVE ATTRIBUTED TO THE ALLEGATIONS OF THE SUDDEN STOPPAGE OF THE UNIT DURING DRIVE. A VISUAL INSPECTION OF THE UNIT DID NOT SHOW ANY SIGNS OF A MECHANICAL DEVIATIONS THAT MAY HAVE ATTRIBUTED TO THE EVENT. END-USERS SISTER ALLEGES THE END USER WAS WEARING A CHEST HARNESS AT THE TIME OF THE EVENT. IT WAS NOTED AT TIME OF INSPECTION THAT THE CHAIR WAS EQUIPPED WITH A CHEST HARNESS, BUT WAS POSITIONED BEHIND THE BACKREST OF THE SEATING SYSTEM WITH A NOTABLE AMOUNT OF DUST COVERING THE HARNESS. UNIT WAS NOT EQUIPPED WITH A LAP POSITIONING BELT DUE TO THE CLIENTS PHYSICAL CONDITION. IT WAS NOTED THAT THE UNIT HAD AN AFTER-MARKET VEHICLE RESTRAINING DEVICE INSTALLED MANUFACTURED BY EZ-LOCK INC. THIS RESTRAINING DEVICE CONSISTS OF A METAL PLATE ATTACHED TO THE BOTTOM OF THE UNITS CHASSIS FRAME WITH A SINGLE BOLT THAT IS THREADED INTO THAT PLATE. THE INTENDED DESIGN OF THIS DEVICE IS TO HOLD THE POWER WHEELCHAIR IN PLACE WHILE BEING TRANSPORTED IN A MOTOR VEHICLE. DURING THE INSPECTION OF THE UNIT, THE BOLT OF THE RESTRAINING DEVICE WAS MEASURED AT BEING APPROXIMATELY 3/4 - 7/8 INCHES ABOVE THE FLOOR. THE END-USERS SISTER, WHO WITNESSED THE EVENT, TESTIFIED THAT THE CHAIR SUDDENLY STOPPED AND THE CARPET UNDERNEATH BUCKLED UP. IT IS BELIEVED THIS REPORTED EVENT WAS CAUSED BY THE BOLT OF THE VEHICLE RESTRAINING DEVICE HAVING CAUGHT THE CARPET INSIDE OF THE BUILDING WHICH COULD STOP THE UNIT FROM FORWARD MOTION. DEALER WILL BE INFORMING END-USER AND CAREGIVERS OF THE FINDINGS AND RECOMMENDING ALTERNATIVE VEHICLE RESTRAINT SYSTEMS, I.E. STRAPS. DEALER WILL ALSO REITERATE THE IMPORTANCE TO USE THE INSTALLED CHEST HARNESS DURING OPERATION OF THE DEVICE. THE DHR WAS REVIEWED AND UNIT WAS BUILT ACCORDING TO SPECIFICATION. IF FURTHER INFORMATION IS RECEIVED THAT DIFFERS FROM PERMOBIL'S CONCLUSION, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT END-USER WAS AT A LOCAL HIGH SCHOOL ATTENDING A BASKETBALL EVENT. AS THE END-USER WAS LEAVING THE EVENT, THEY WERE TRAVERSING AROUND A CORNER INSIDE THE BUILDING WHERE IT WAS REPORTED THE CHAIR SUDDENLY STOPPED. THIS ALLEGED SUDDEN STOP REPORTEDLY CAUSED THE END-USER TO FALL FORWARD, SUBSEQUENTLY BEING THROWN FROM THE SEATING TO THE GROUND. REPORTS ARE THE END USER WAS RUSHED TO THE HOSPITAL WITH HEAD INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270281 PERMOBIL F3 POWERED WHEELCHAIR ITI PERMOBIL INC. F3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization