BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 2820359 · Received November 6, 2012

    Report

    Report Number
    2250051-2012-00268
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 28, 2012
    Report Date
    November 6, 2012
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT. THE FSE FOUND THE 2-POLE CABLE IN POSITION #3, THE TIP CLAMP, CABLE AND CONNECTOR BOARD IN POSITION #10 WERE DAMAGED. THE FSE REPLACED THE 2-POLE CABLE, TIP CLAMP, CABLE AND CONNECTOR BOARD. THE FSE PERFORMED SPLLD CHECKING PROCEDURE AND TESTED SUMMIT WITH OAS USER SOFTWARE. THE INSTRUMENT WAS TESTED WITHOUT PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE ORTHO SUMMIT SAMPLE HANDLING SYSTEM INSTRUMENT REPORTEDLY DID NOT PIPETTE SAMPLE AND DID NOT GENERATE AN ERROR MESSAGE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE PIPETTOR MMH HAMILTON BONADUZ AG 936400

    Patients

    Seq Age Sex Outcome Treatment
    1