BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 4102689 · Received August 28, 2014

    Report

    Report Number
    2023446-2014-00142
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE MOTOR BROKE OFF THE MOUNT DURING SPIN CYCLE CAUSING THE UNIT TO VIBRATE EXCESSIVELY UNTIL IT FELL ON THE FLOOR FROM THE BENCH TOP. CUSTOMER STATED THERE DID NOT SEEM TO BE DAMAGE TO THE BOWL BUT THE LID MAY HAVE CRACKED THE LOCK GUIDE DURING THE INCIDENT. THERE WAS NO EXPOSURE TO SAMPLE, OR INJURY AND NO MEDICAL ATTENTION REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A ROTOR BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526666 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1