BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2771498 · Received October 4, 2012

    Report

    Report Number
    1525712-2012-01727
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    October 3, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3G, SERIAL NUMBER/DATE CODE UNKNOWN IS OF AN UNKNOWN AGE. THE OWNER'S MANUAL PART NUMBER 1143151 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED. THE INITIAL REPORTER STATED SHE HAS HAD THIS DEVICE SINCE 2007. NO FURTHER INFORMATION ON THE OUTCOME OF ANY POSSIBLE MEDICAL INTERVENTION THIS END USER MAY HAVE RECEIVED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER MENTIONED THE CHAIR WOULDN'T MOVE AND BELIEVES ITS DUE TO THE MOTORS. REPORTEDLY SHE HAD TRIED TURNING THE CHAIR OFF AND BACK ON, THEN IT WOULD MOVE. NOW SHE IS UNABLE TO TILT AND RECLINE. SHE MENTIONED THAT HER BOTTOM IS BECOMING SORE AND RED BECAUSE SHE IS UNABLE TO TILT AND RECLINE. SHE WILL BE SEEING HER DOCTOR ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3G STORM

    Patients

    Seq Age Sex Outcome Treatment
    1 48 Other| R