BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOENERGY INTEGRAL

    MDR report key: 5580346 · Received April 15, 2016

    Report

    Report Number
    9615892-2016-00006
    Event Type
    Malfunction
    Date Received
    April 15, 2016
    Date of Event
    March 21, 2016
    Report Date
    April 15, 2016
    Manufacturer
    OTTO BOCK HEALTHCARE PRODUCTS GMBH
    Product Code
    IQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE MALFUNCTION IS A DEFECTIVE ELECTRONIC COMPONENT OF THE BATTERY CHARGER.

    Description of Event or Problem · 1

    THE MYO ENERGY INTEGRAL BATTERY WAS CONNECTED TO THE CHARGER BY THE CPO PRIOR TO THE FITTING OF AN EXTERNAL UPPER LIMB PROSTHESIS. AFTER ABOUT TWO (2) HOURS OF CHARGING THE BATTERY INFLAMED. THE FIRE WAS DISCOVERED IMMEDIATELY BY AN EMPLOYEE AROUND AND COULD BE EXTINGUISHED. NO CONSEQUENCES OR IMPACT TO PATIENT OR OTHER PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238429 MYOENERGY INTEGRAL BATTERY PACK IQZ OTTO BOCK HEALTHCARE PRODUCTS GMBH 757B35=0 0012 2016 02

    Patients

    Seq Age Sex Outcome Treatment
    1