BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA PLUS

    MDR report key: 1950878 · Received December 2, 2010

    Report

    Report Number
    3004468271-2010-00043
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPH OF A BATTERY WITH A MALFORMED SHAPE THAT WILL NOT ALLOW IT TO FULLY ATTACH TO A SARA PLUS ACTIVE LIFT WAS SENT TO ARJOHUNTLEIGH. THE USER SAYS THEY HAVE THREE SUCH BATTERIES. FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE BATTERY IS MALFORMED. THE BACK IS SEPARATING FROM THE FRAMEWORK, PREVENTING INTEGRATION WITH THE SARA PLUS LIFT. WHILE NO BATTERY FLUID WAS FOUND OUTSIDE THE CASING, THE MANUFACTURER HAS DETERMINED THE POTENTIAL EXISTS; IF SO, THAT FLUID COULD CAUSE INJURY TO BARE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA PLUS ACTIVE FLOOR LIFTS FNG MEDIBO MEDICAL PRODUCTS NV HEP0001-US

    Patients

    Seq Age Sex Outcome Treatment
    1