BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN EXPRESS 4

    MDR report key: 3802318 · Received February 21, 2014

    Report

    Report Number
    2023446-2014-00021
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    July 17, 2013
    Report Date
    November 8, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY FILED BY A USER FACILITY UNDER MEDWATCH MDR REPORT (B)(4). AS A RESULT, FURTHER DETAILS OF THE EVENT ARE NOT AVAILABLE TO THE MANUFACTURE. THE MANUFACTURER BECAME AWARE OF THIS EVENT VIA REVIEW OF REPORTED INCIDENTS ON THE MAUDE DATABASE.

    Description of Event or Problem · 1

    USER FACILITY REPORTED A BROKEN LATCH ON THEIR STATSPIN EXPRESS 4 CENTRIFUGE WHICH DID NOT PREVENT THE LID FROM OPENING WHILE SPINNING OF SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108874 STATSPIN EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1