BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HILL-ROM ADVENTA 2

    MDR report key: 4289932 · Received November 13, 2014

    Report

    Report Number
    3004938766-2014-00007
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 21, 2014
    Report Date
    November 3, 2014
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    HST
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 0-00124-001 (CUSTOM BED ADAPTOR) WAS REVIEWED BY QA, ASSEMBLY AND CUSTOMER SERVICE PERSONNEL FOR ANY OBVIOUS DEFECTS. NONE WERE FOUND AND THE TORQUE HANDLE ITSELF WAS FOUND TO BE WORKING ACCORDINGLY. SAID PERSONNEL THEN ATTEMPTED TO REPRODUCE THE CUSTOMER'S COMPLAINT OF SLIPPAGE BY MOUNTING IT TO A SILHOUETTE SCAN BOARD ASSAY. AFTER A FEW ATTEMPTS THE SLIPPAGE WAS REPRODUCED WHEN APPROX 220+ LBS WAS APPLIED. THE ADAPTOR WAS DISPOSITIONED FOR REPAIR TO RECEIVE A BRAND NEW BASE. A CLINICAL APPLICATIONS SPECIALIST WAS ASSIGNED TO BRING THE REPAIRED ADAPTOR TO THE CUSTOMER AND PROVIDE TRAINING. THE INVESTIGATION DONE DURING THE REPAIR FOUND THE FAILURE TO BE ATTRIBUTED TO WEAR AND TEAR OF THE POSITION STABILIZERS MOUNTED WITHIN THE BASE OF THE BED ADAPTOR THAT PROVIDE RELIABLE STABILIZATION FOR THE SCAN BOARD WHEN TORQUED DOWN WITH THE BED ADAPTOR'S CORRESPONDING TORQUE HANDLE. PREVENTIVE MAINTENANCE CHECKLISTS USED BY FIELD SERVICE PERSONNEL WILL INCLUDE REVIEWING FOR SIMILAR WEAR AND IF FOUND TO BE PROACTIVELY REPLACED AS NEEDED ON ALL FUTURE SERVICE VISITS. [THIS IS IN RESPONSE TO THE ACCOMPANYING DOCUMENT (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER USES A CUSTOM BED ADAPTER ASSY (0-00124-001 HILL-ROM ADVENTA 2) TO ASSIST WITH THEIR CT SCANNING FOR THEIR PTS. THE CUSTOM ASSEMBLY BEGAN TO MINIMALLY SLIP ALONG ITS MATING SILHOUETTE SCAN BOARD ASSY WHEREIN THE ACCOMPANYING TORQUE HANDLE (USED TO TIGHTEN THE CUSTOMER BED ADAPTER IN PLACE) WOULD NOT FASTEN PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734542 HILL-ROM ADVENTA 2 BED ADAPTER HST NEUROLOGICA CORPORATION 0-00124-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other