BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY

    MDR report key: 2314460 · Received October 14, 2011

    Report

    Report Number
    2428983-2011-00003
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    March 23, 2011
    Report Date
    October 14, 2011
    Manufacturer
    GF HEALTH PRODUCTS, INC./ DBA BASIC AMERICAN
    Product Code
    FNL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION FROM (B)(4): "IT HAS NOT BEEN POSSIBLE TO RE-CREATE THE FAILURE. EVALUATING THE RETURNED UNITS AND THE DESIGN IT IS EVIDENT A DOUBLE FAULT HAS OCCURRED. THE X-RAY IS SHOWING A DEFECTIVE MOTOR CABLE WITH A BAD FEEDBACK (END STOP) WIRE. THE MOST PLAUSIBLE EXPLANATION IS MISSING THE END STOP SIGNAL FROM THE ACTUATOR DUE TO THE MOTOR CABLE AND INPUT OF CONSTANT ACTIVATION FROM HANDSET OR OTHER EXTERNAL DEVICE (LAYING ON HAND PENDANT, UNINTENDED ACTIVATION OF BUTTON IN HOLSTER OR BETWEEN MATTRESS/FRAME/WALL). (B)(4) IS CURRENTLY SELLING APPROX (B)(4) PCS OF THESE SYSTEMS ANNUALLY, WITH SIMILAR CONFIGURATION ((B)(4)) AND HAVE HAD NO SUCH FAILURE PREVIOUSLY REPORTED. (B)(4). DESPITE THE VERY UNPLEASANT ODOR WHICH MAY BE ASSOCIATED WITH FIRE, THERE WAS NO SUCH THING AND THE PRODUCT FAILED IN A SAFE MODE AS INTENDED." (B)(4). ADD'L MODEL#: 0277020-650 MOTOR CABLE, (B)(4).

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2011, (B)(6), ALLEGED THAT THE ACTUATOR CASING FROM GF HEALTH PRODUCTS, INC. (GFHP) LIBERTY MODEL BED SMELLED LIKE IT WAS ON FIRE. THE ACTUATOR CASING AND MOTOR ASSEMBLY IS MANUFACTURED BY (B)(4). THIS COMPONENT IS USED FOR THE LIBERTY MODEL BED MANUFACTURED BY GFHP. ON (B)(4) 2011, GFHP ISSUED AN RGA ((B)(4)) AND DROP SHIPPED THE COMPONENTS DIRECTLY FROM THE CUSTOMER ((B)(6)) TO THE MFR ((B)(4).) FOR TESTING. IT SHOULD ALSO BE NOTED, THERE WAS NO REPORT INJURY ASSOCIATED WITH THIS ACTUATOR MALFUNCTION. A WORKER DETECTED A "HOT" SMELL, AND THE BED WAS TAKEN OUT OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY LIBERTY BED FNL GF HEALTH PRODUCTS, INC./ DBA BASIC AMERICAN LA27-U094-00 ACTUATOR 07/27/2010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA