BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C300

    MDR report key: 4309104 · Received December 9, 2014

    Report

    Report Number
    1221084-2014-00040
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    October 29, 2014
    Report Date
    December 9, 2014
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLIENT WAS RIDING ON PUBLIC TRANSPORTATION WITH OUT HAVING THE CHAIR TIED DOWN. PAGE 84 OF THE PERMOBIL C300 MANUAL CLEARLY STATES. "TRANSPORTATION IN MOTOR VEHICLES. PERMOBIL RECOMMENDS THAT USERS NOT BE TRANSPORTED IN ANY KIND OF VEHICLE WHILE IN THEIR WHEELCHAIR, UNLESS THE USER IS IN AN APPROVED PERMOBIL WHEELCHAIR CONFIGURATION, HAS SECURED THE WHEELCHAIR ACCORDING TO THE APPROPRIATE CRASH TEST STANDARDS, AND IS USING A SEATBELT ATTACHED TO THE VEHICLE. THE ONLY OTHER SAFE ALTERNATIVE IS THAT USERS BE TRANSFERRED INTO FACTORY VEHICLE SEATING FOR TRANSPORTATION AND USE SAFETY RESTRAINTS MADE AVAILABLE BY THE AUTO INDUSTRY. UNLESS USING A CRASH-TESTED APPROVED PERMOBIL WHEELCHAIR, NEVER SIT IN YOUR WHEELCHAIR WHILE IN A MOVING VEHICLE. IN AN ACCIDENT OR SUDDEN STOP, YOU MAY BE THROWN FROM THE CHAIR AND SERIOUSLY INJURED OR KILLED. PERMOBIL POSITIONING BELTS ARE DESIGNED TO POSITION THE USER ONLY AND NOT TO PROTECT YOU IN THE EVENT OF A MOTOR VEHICLE ACCIDENT. THE POSITIONING BELTS DO NOT REPLACE USE OF A VEHICLE MOUNTED RESTRAINT." THIS CLIENT DID NOT HAVE THE CHAIR PROPERLY RESTRAINED AND DID NOT HAVE HERSELF PROPERLY RESTRAINED. THIS IS A CASE OF USER ERROR. DEVICE IS NOT THE CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    THIS CHAIR TIPPED OVER WHILE THE CLIENT WAS RIDING IN IT ON PUBLIC TRANSPORTATION. THE CHAIR WAS NOT PROPERLY TIED DOWN AND THE CLIENT WAS NOT RESTRAINED BY A VEHICLE SAFETY BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795983 PERMOBIL C300 POWER WHEELCHAIR ITI PERMOBIL INC. C300

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O