BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 2

    MDR report key: 3897479 · Received May 22, 2014

    Report

    Report Number
    2023446-2014-00059
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE LID PREMATURELY DISENGAGED DURING A CYCLE. CUSTOMER STATED THE LID WOULD OPEN WHEN THE POWER WAS OFF BY JUST PULLING UP ON THE LID. THE RUN BUTTON ALSO DID NOT WORK PROPERLY. STATSPIN CENTRIFUGE REPORTED. NO INJURIES REPORTED AS A RESULT.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE LID WAS NOT LATCHED ON THE STATSPIN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307023 EXPRESS 2 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1