BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENOR (BATTERY/CHARGER)

    MDR report key: 1971755 · Received January 12, 2011

    Report

    Report Number
    3004468271-2011-00006
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    ADAM (FACILITY REP) RECEIVED A PHONE CALL FROM THE AREA WHERE THE CHARGER AND THE BATTERIES ARE LOCATED THAT THEY HAD AN ODD STAINING ON THE FLOOR. HE THEN WENT TO REVIEW THE SITUATION AND SAW THE STAINING IMMEDIATELY UNDER THE BATTERY CHARGING STATION. THE AGGRESSIVE NATURE IN WHICH THE LIQUID HAD ATTACHED THE FLOORING MADE ADAM BELIEVE THE "LEAKING" LIQUID TO BE "ACID" FROM ONE OR BOTH OF THE BATTERIES. ADAM DID NOT SEE ANY IMMEDIATE DAMAGE TO THE OUTSIDE CASING OF THE BATTERY THAT WOULD INDICATE THE BATTERY WAS DROPPED IN ANY WAY. ADAM REMOVED THE BATTERIES AND CHARGER FROM USE AND TOOK PICTURE AND FORWARDED THEM TO ARJOHUNTLEIGH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENOR (BATTERY/CHARGER) PASSIVE FLOOR LIFT FSA MEDIBO MEDICAL PRODUCTS NV KHA1010-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other