BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 4071904 · Received August 12, 2014

    Report

    Report Number
    2023446-2014-00120
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE EXPRESS 4 UNIT HAD EVIDENCE OF CHARRED MATERIALS AT THE END OF CABLE CONNECTED TO BOARD. THERE WAS NO BURNING SMELL, NO INJURIES AND NO ONE REQUIRED MEDICAL ATTENTION. NO INJURIES, OPEN FLAMES, OR SMOKE WAS REPORTED, NOR FIRE DEPARTMENT BEING CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPROTED EXPRESS 4 UNIT WAS NOT POWERED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479039 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1