BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN EXPRESS 2 CENTRIFUGE

    MDR report key: 3639659 · Received December 31, 2013

    Report

    Report Number
    2023446-2013-00047
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    September 20, 2013
    Report Date
    December 31, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STATSPIN CENTRIFUGE REPORTING LATCH UNLOCKS AND RELEASES WHEN THE STOP BUTTON IS PRESSED, WHICH CAN STILL RELEASE INNER CONTENTS. NO INJURIES REPORTED. THE INSTRUMENT WAS REPAIRED AND WAS VERIFIED TO BE OPERATIONAL VIA INSTRUMENT PERFORMANCE TESTS WITH 120V AND 1 HOUR BURN WITH NO ERRORS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE LATCH OPENS WHEN THE STOP BUTTON IS SELECTED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682830 STATSPIN EXPRESS 2 CENTRIFUGE STATSPIN EXPRESS 2 JQC IRIS INTERNATIONAL EXPRESS 2

    Patients

    Seq Age Sex Outcome Treatment
    1