BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WA96 PLUS

    MDR report key: 3812734 · Received April 25, 2014

    Report

    Report Number
    2919016-2014-00018
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT'S ACCESS DOOR HINGE ASSEMBLY SPRING BECAME DETACHED. THERE WAS NO REPORT OF IMPACT TO PANEL RESULTS OR PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251165 WA96 PLUS WALKAWAY 96 PLUS LRG SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1