BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2140563 · Received June 16, 2011

    Report

    Report Number
    1525712-2011-00263
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR ALLEGES THE CONSUMER SAW SMOKE COMING FROM THE WHEEL CHAIR BATTERY CHARGER. THE SMOKE ISSUE COULD NOT BE REPRODUCED UPON RECEIPT OF THE BATTERY CHARGER BY DISTRIBUTOR. A LIGHT ON THE BATTERY CHARGER WAS FOUND TO BE NON-FUNCTIONAL BY THE DISTRIBUTOR. MAINTENANCE HISTORY IS UNKNOWN. PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION, SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES SHE SAW SMOKE COMING FROM THE BATTERY CHARGER. THE DEALER PICKED UP THE UNIT AND CANNOT DUPLICATE THE ALLEGED INCIDENT. THE LIGHT ON THE UNIT IS NOT COMING ON. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE ITI INVACARE M41SR20R

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR