BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE

    MDR report key: 1971721 · Received January 19, 2011

    Report

    Report Number
    3004468271-2011-00009
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    January 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE BATTERY IS GETTING HOT AND THAT THERE IS A BURNING SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE ACTIVE FLOOR LIFT FSA MEDIBO MEDICAL PRODUCTS NV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other