BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2862351 · Received December 10, 2012

    Report

    Report Number
    1525712-2012-02750
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE AGE OF THE POWERED WHEELCHAIR IS UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1143206 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED. PLEASE NOTE ADDITIONAL INFORMATION RECEIVED ON THIS INCIDENT: WHEN LIFTING FOOTBOARD, IT WOULD NOT STAY UP. IT WOULD JUST FALL ON ITS' OWN. END USER TRIPPED OVER FOOTBOARD AND WHEN THE END USER FELL, IT CAUSED HIM TO LAND ON HIS ELBOWS WHICH SCRAPED THEM ALL UP. END USER WAS TRANSFERRING OUT OF THE CHAIR WHEN THIS HAPPENED. EMS WAS CALLED TO END USER'S HOME TO ASSIST GETTING HIM OFF THE FLOOR. IT WAS LEARNED THAT NO FURTHER MEDICAL ATTENTION WAS GIVEN TO THE END USER FOR THE FALL. SINCE THE END USER CALLED FOR EMERGENT MEDICAL ASSISTANCE THIS INCIDENT IS BEING FILED AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    A REPORT HAS BEEN PROVIDED BY A CAREGIVER OR FAMILY MEMBER ON BEHALF OF THE END USER. IT WAS REPORTED THAT THE FOOTBOARD WILL NOT SUPPORT FEET. PLATE DROPS TO THE FLOOR. PLEASE REVIEW ADDITIONAL ATTACHED INFORMATION FOR FURTHER DETAIL. PLEASE NOTE ANY FURTHER INFORMATION OR PRODUCT EVALUATION RECEIVED WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M41

    Patients

    Seq Age Sex Outcome Treatment
    1 78 Other| R