BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2052482 · Received March 15, 2011

    Report

    Report Number
    1525712-2011-00092
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    March 11, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHARGER PLUG ALLEGEDLY WAS MELTED. THE CHARGER AND COMPONENTS WERE RECEIVED WITH THE CABLE CUT AND CHARGER PLUG DISASSEMBLED. THERE WAS NO SIGNIFICANT MELTING OF INSULATION OTHER PLASTIC PARTS OF THE CONNECTOR OR CABLE. THE ONLY DAMAGE OBSERVED WAS THE PLUG INTERNALLY THERE IS NOT HISTORY TO SUGGESTS A PRODUCT PROBLEM. DUE TO THE COMPONENTS BEING RECEIVED CUT AND DISASSEMBLED NO DETERMINATION COULD BE MADE. THE CHARGER WAS REPLACED. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    THE CHARGER CORD WAS ALLEGEDLY MELTED. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE 1123249

    Patients

    Seq Age Sex Outcome Treatment
    1