BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2143192 · Received June 28, 2011

    Report

    Report Number
    1525712-2011-00305
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. ALLEGEDLY, UPON LEAVING (B)(6) RESTAURANT, THE CHAIR BEGAN EMITTING SMOKE FROM THE BATTERY AREA. ALLEGEDLY, THE CAREGIVER REMOVED THE CONSUMER FROM THE CHAIR AS THE SMOKE WAS BEING EXTINGUISHED. ALLEGEDLY, THE RESTAURANT EMPLOYEES USED A FIRE EXTINGUISHER ON THE CHAIR AND CALLED THE FIRE DEPARTMENT. IT IS UNKNOWN WHICH COMPONENTS IN THE BATTERY AREA GENERATED THE SMOKE. IT IS UNKNOWN IF THE CONSUMER IS A CIGARETTE OR CIGAR SMOKER. IT IS UNKNOWN IF A LIT FOREIGN OBJECT BECAME LODGED IN THE BATTERY AREA OF THE WHEELCHAIR. MDR FILED.

    Description of Event or Problem · 1

    UPON LEAVING (B)(6) RESTAURANT, THE CHAIR ALLEGEDLY EMITTED SMOKE FROM THE BATTERY AREA. THE RESTAURANT EMPLOYEES USED A FIRE EXTINGUISHER ON THE CHAIR AND CALLED THE FIRE DEPARTMENT. THE CAREGIVER REMOVED THE CONSUMER FROM THE CHAIR AS THE SMOKE WAS BEING EXTINGUISHED. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46