BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2170501 · Received July 21, 2011

    Report

    Report Number
    1525712-2011-00365
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ISSUED TO HAVE THE DEVICE RETURNED. EVALUATION PERFORMED: THE BATTERY WAS RETUNED AND EVALUATED. VISUALLY, THERE WERE NO SIGNS OF OVERHEATING OR BURNING, FUNCTIONALLY, THE BATTERY WAS RUN FOR AN HOUR AND CHECKED WITH A LASER TEMPERATURE GUN ON THE HOUSING OF THE BATTERY ON THE TOP AND BOTH SIDES. THREE READINGS WERE TAKEN AND AVERAGED. AT START UP THE AVERAGE TEMP WAS 92F DEGREES AND AFTER ONE HOUR 113F DEGREES. THE BATTERY ISSUE COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED TO HAVE THE DEVICE RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR 8923 ISSUED MFG REPORT # 1525712-2011-00365 WITH INVACARE (B)(4) AS THE MANUFACTURER. THE CORRECT MANUFACTURER IS INVACARE (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE BATTERY CHARGER GOT SO HOT, IT BURNED HIS HANDS. NO SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE BATTERY CHARGER GOT SO HOT, IT BURNED HIS HANDS. NO SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE BATTERY CHARGER GOT SO HOT, IT BURNED HIS HANDS. NO SERIOUS INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1