BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1458724 · Received May 6, 2009

    Report

    Report Number
    1823260-2009-03217
    Event Type
    Malfunction
    Date Received
    May 6, 2009
    Date of Event
    April 14, 2009
    Report Date
    May 6, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER STATED THE VALVE BODY CAP CRACKED ON THE WATER RESERVOIR AND THE ANALYZER LEAKED ONTO THE CART AND ONTO THE FLOOR AT THE BACK OF THE ANALYZER. THE WATER WAS NOT IN A WALKWAY. NO ERRONEOUS RESULTS WERE GENERATED. NO OPERATORS WERE HARMED. THE USER REPLACED THE CAP WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK