BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 3

    MDR report key: 4030363 · Received July 29, 2014

    Report

    Report Number
    2023446-2014-00098
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STATSPIN EXPRESS 3 CENTRIFUGE REPORTED LID LATCH FAILURE WHERE THE UNIT IS ABLE TO SPIN WITHOUT LID LATCHING. NO INJURIES REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CENTRIFUGE CYCLE SPINS WITHOUT LID LATCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442491 EXPRESS 3 STATSPIN CENTRIFUGE JQC IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1