BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKAWAY 96 PLUS

    MDR report key: 3960839 · Received June 27, 2014

    Report

    Report Number
    2919016-2014-00029
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LRG
    PMA / PMN Number
    K911400
    Removal / Correction Number
    2919016-06/09/14-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT QUALITY ISSUE ASSOCIATED WITH AN INHERENT DEVICE AND/OR DEVICE COMPONENT CHARACTERISTIC THAT IS NOT SATISFACTORY AS SPECIFIC OR DELIVERED. SIEMENS HEALTHCARE DIAGNOSTICS INC. CONDUCTED A FIELD CORRECTION, INTERNAL NUMBER (B)(4). A WRITTEN CUSTOMER NOTIFICATION WAS SENT ON 06/2014 TO ALL CUSTOMERS AFFECTED NOTIFYING THEM OF THE SPRINGS CONTAINED IN THE ACCESS DOOR HINGE ASSEMBLY ON THE WALKAWAY PLUS INSTRUMENTS ARE BECOMING DETACHED CAUSING PREMATURE FAILURE OF THE HINGE ASSEMBLY AND A POTENTIAL SAFETY ISSUE FORT THE CUSTOMER. THE NOTIFICATION ALSO INCLUDES ACTIONS TO BE TAKEN BY CUSTOMERS. THE FDA SAN FRANCISCO DISTRICT OFFICE WAS NOTIFIED ON 06/09/2014 OF THE REMEDIAL ACTION (REPORT NO. 2919016-06/09/14-001-C). A SIEMENS REPRESENTATIVE WILL CONTACT THE CUSTOMER OVER THE NEXT FEW MONTHS TO SCHEDULE A VISIT TO CORRECT THIS ISSUE WITH THE ACCESS DOOR HINGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BROKEN HINGES WERE OBSERVED DUE TO THE RIVETS WEARING OUT ON THE SPRING LOAD CAUSING FAILURE OF THE DOOR ASSEMBLY OF THE WALKAWAY PLUS INSTRUMENT. THE SPRING FELL OUT DURING OPENING/CLOSING OF THE DOOR. NO REPORT OF THE ADVERSE EVENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376156 WALKAWAY 96 PLUS WALKAWAY 96 PLUS LRG SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1