BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL M300

    MDR report key: 5196748 · Received November 2, 2015

    Report

    Report Number
    1221084-2015-00040
    Event Type
    Malfunction
    Date Received
    November 2, 2015
    Date of Event
    September 29, 2015
    Report Date
    November 2, 2015
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K103477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY THE COMPLAINANT FAILED TO INCLUDE A VALID DEVICE SERIAL NUMBER. BASED IN THE LACK OF THIS INFORMATION, PERMOBIL WAS UNABLE TO LOCATE THE DHR FOR THE ASSOCIATED DEVICE. THE DETAILS SURROUNDING THE EVENT CONFIRM THAT THE END USER WAS OCCUPYING THE WHEELCHAIR DURING TRANSPORTATION. PERMOBIL TRANSPORTATION WARNING IS FOUND IN THE M300 OWNER'S MANUAL (ATTACHED DOCUMENT) AND IS SUMMARIZED BELOW: "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. PERMOBIL'S "POSITIONING BELTS" ARE DESIGNED TO POSITION THE USER ONLY AND NOT FOR PROTECTION IN A MOTOR VEHICLE ACCIDENT. THE POSITIONING BELTS DO NOT REPLACE USE OF A VEHICLE MOUNTED RESTRAINT. THE ROOT CAUSE OF THIS INCIDENT IS ASSUMED TO BE IMPROPER RESTRAINING PERFORMED ON THE WHEELCHAIR AND/OR THE END USER. DUE TO THE LACK OF DETAILS AND COMMUNICATION A FULL INVESTIGATE NOR A CORRECTIVE ACTION CANNOT BE PURSUED. THE MISSING INFORMATION WITHIN THIS MDR WAS ATTEMPTED TO BE OBTAINED THROUGH COMMUNICATION WITH THE CAREGIVER BUT WAS UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE SUBMITTED IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE END USER WAS ON RTA BUS AND WHEN THE BUS DRIVER TURNED A CORNER THE WHEELCHAIR TILTED AND THE POSITIONAL BELT BROKE. THE END USER FELL OUT OF THE WHEELCHAIR AND HIT HER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724917 PERMOBIL M300 WHEELCHAIR, POWERED ITI PERMOBIL INC. M300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization