BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKAWAY 96 PLUS

    MDR report key: 3960837 · Received June 27, 2014

    Report

    Report Number
    2919016-2014-00026
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 14, 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
    IA, 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 (B)(4) DISTRICT OFFICE WAS NOTIFIED ON 06/09/2014 OF THE REMEDIAL ACTION (REPORT NO. 2919016-06/09/14-001-C). SIEMENS CUSTOMER SERVICE ENGINEER REPLACED THE ACCESS DOOR AND THE WALKAWAY PLUS INSTRUMENT IS UP AND RUNNING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIN THAT HOLDS THE PIVOT PIN ON THE HINGE WAS INTACT BUT THE SPRING WAS NO LONGER THERE AND LIKELY POPPED OUT WHILE THE DOOR WAS CLOSED. THE SPRING WAS FOUND IN THE ACCESS DOOR AREA. NO DAMAGE TO THE INTERIOR OF THE WALKAWAY PLUS INSTRUMENT. NO REPORT OF ADVERSE EVENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375935 WALKAWAY 96 PLUS WALKAWAY 96 PLUS LRG SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1