BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WA96 PLUS

    MDR report key: 4102326 · Received August 27, 2014

    Report

    Report Number
    2919016-2014-00035
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LRG
    PMA / PMN Number
    K911400
    Removal / Correction Number
    Z-1990-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT QUALITY ISSUE ASSOCIATED WITH AN INHERENT DEVICE AND/OR DEVICE COMPONENT CHARACTERISTICS THAT IS NOT SATISFACTORY AS SPECIFIC OR DELIVERED. METHOD: ACTUAL DEVICE NOT EVALUATED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSIONS: DEVICE NOT RETURNED. SIEMENS HEALTHCARE DIAGNOSTICS INC. CONDUCTED A FIELD CORRECTION, INTERNAL NUMBER (B)(4) ON THE ISSUE WITH THE ACCESS DOOR HINGE. A WRITTEN CUSTOMER NOTIFICATION WAS SENT ON (B)(4) 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 FOR THE CUSTOMER. THE NOTIFICATION ALSO INCLUDES ACTIONS TO BE TAKEN BY THE CUSTOMERS. THE FDA SAN FRANCISCO DISTRICT OFFICE WAS NOTIFIED ON JUNE 9, 2014 OF THE REMEDIAL ACTION (REPORT NO. 2919016-06/09/14-001-C). ON (B)(4) 2014, SIEMENS REPRESENTATIVE HAS CONFIRMED THAT APPROPRIATE MODIFICATIONS TO THE HINGE WERE PERFORMED. CUSTOMER CONFIRMED THE SYSTEM'S PERFORMANCE AND REPORTED THAT IT IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOWER PANEL ACCESS DOOR HINGE FAILED. THE HINGE PIN APPEARED TO HAVE FALLEN OUT AND THE SPRING FELL WHEN THE PANEL ACCESS DOOR WAS OPENED. NO INJURY OR ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522631 WA96 PLUS WALKAWAY 96 PLUS LRG SIEMENS HEALTHCARE DIAGNOSTICS B1018-284 NA

    Patients

    Seq Age Sex Outcome Treatment
    1