BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFOOT BIOM

    MDR report key: 2370020 · Received November 10, 2011

    Report

    Report Number
    3008869754-2011-00001
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    October 12, 2011
    Report Date
    October 13, 2011
    Manufacturer
    IWALK INC.
    Product Code
    ISW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY CHARGER ACCESSORY IS BEING REPLACED FOR EACH PT WITH A UNIT THAT HAS PREVENTIVE MEASURES IMPLEMENTED TO ASSURE IT IS IN THE PROPER CHARGING MODE FOR THE LITHIUM POLYMER BATTERIES. THE USER WILL NO LONGER BE ABLE TO CHANGE THE CHARGING MODE OF THE BATTERY CHARGER ACCESSORY. ALL OTHER CHARGING MODES ARE BEING DISABLED. THE PROVIDED LITHIUM POLYMER BATTERIES WILL NO LONGER BE ABLE TO BE CHARGED IN ANY MODE OTHER THAN FOR A LITHIUM POLYMER BATTERY. AN UPDATED USER MANUAL WILL ACCOMPANY THE REPLACEMENT ACCESSORY BATTERY CHARGER.

    Description of Event or Problem · 1

    PROSTHETIST RECEIVED A MESSAGE FROM A PT THAT THE BATTERY (LITHIUM POLYMER) SUDDENLY CAUGHT FIRE WHILE BEING CHARGED IN THE PROVIDED ACCESSORY BATTERY CHARGER. THE CHARGER ACCESSORY AND BATTERY WERE RETURNED FOR ANALYSIS. UPON EXAMINATION, IT WAS DISCOVERED THAT THE BATTERY CHARGER HAD BEEN PLACED IN THE NICD BATTERY CHARGING MODE, AN IMPROPER CHARGING MODE FOR THE LITHIUM POLYMER SYSTEM BATTERY. THERE WAS NO INJURY TO THE PT OR OTHER INDIVIDUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFOOT BIOM ISW IWALK INC. 11-08A

    Patients

    Seq Age Sex Outcome Treatment
    1