BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA LABCELL

    MDR report key: 3852030 · Received June 5, 2014

    Report

    Report Number
    2432235-2014-00355
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K083339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE ADVIA LABCELL, THE CSE DETERMINED THAT THE AUTOMATION ARM HAD MALFUNCTIONED. THE CSE REPLACED THE AUTOMATION ARM. THE CAUSE OF THE ADVIA 1800 MONITOR FALLING ONTO THE OPERATOR WAS A MALFUNCTION OF THE AUTOMATION ARM. THIS DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE AUTOMATION ARM OF AN ADVIA LABCELL SAMPLE MANAGER BROKE WHILE HOLDING THE MONITOR OF AN ADVIA 1800 INSTRUMENT, CAUSING THE MONITOR TO FALL ONTO THE OPERATOR. THE MONITOR SCRAPED THE OPERATOR'S NOSE AND CAUSED IT TO BLEED AS A RESULT OF THE INCIDENT. THE OPERATOR WAS EVALUATED BY A PHYSICIAN AT AN EMERENCY ROOM, WHO DETERMINED THAT HER NOSE WAS NOT FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329261 ADVIA LABCELL LABORATORY AUTOMATION SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA LABCELL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR