BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLAB® ANALYTICAL WORKCELL

    MDR report key: 3171149 · Received June 14, 2013

    Report

    Report Number
    1226181-2013-00266
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1226181-10/17/2012-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC DETERMINED THAT THE CAUSE OF THE OPERATOR FALLING, WAS DUE TO A PROTRUSION OF A PIN BELOW THE FRAME OF THE INPUT/OUTPUT MODULE. AN URGENT CUSTOMER NOTIFICATION, (B)(4); OCTOBER 2012, WAS PROVIDED TO ALL STREAMLAB AUTOMATION SOLUTIONS CUSTOMERS TO INFORM THEM THAT SIEMENS HEALTHCARE DIAGNOSTICS HAS RECEIVED REPORTS FROM CUSTOMERS THAT THE SMALL PINS AT THE BOTTOM OF THE CENTER DOOR PANEL OF THE INPUT/OUTPUT MODULE, WHICH PROTRUDE APPROXIMATELY 5/8 INCH (16 MM), HAVE CONTRIBUTED TO TWO TRIP AND FALL INCIDENTS. CUSTOMERS ARE ADVISED THAT WHEN WORKING IN THE AREA OF THE INPUT/OUTPUT MODULE TO BE AWARE OF THE TWO PINS THAT PROTRUDE AND TO USE CAUTION. THEY ARE ASKED TO NOTIFY ALL STREAMLAB OPERATORS IN THE LABORATORY TO THIS POTENTIAL SAFETY ISSUE AND TO POST THE NOTICE ON OR NEAR THE SYSTEM.

    Description of Event or Problem · 1

    AN OPERATOR WAS PERFORMING STANDARD OPERATIONS ON THE STREAMLAB CORE UNIT. THE OPERATOR TRIPPED ON ONE OF THE PINS THAT PROTRUDE BELOW THE FRAME OF THE INPUT/OUTPUT MODULE AND FELL DOWN. THE OPERATOR BRUISED HER KNEE AND DID NOT REQUIRE MEDICAL TREATMENT. THE OPERATOR REPORTED NO SUSTAINED INJURY DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271007 STREAMLAB® ANALYTICAL WORKCELL STREAMLAB ANALYTICAL WORKCELL LXG SIEMENS HEALTHCARE DIAGNOSTICS STREAMLAB ANALYTICAL WORKCELL

    Patients

    Seq Age Sex Outcome Treatment
    1