BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 4102683 · Received August 28, 2014

    Report

    Report Number
    2023446-2014-00140
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    FA-14002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PCB CONTROL BOARD AND THE POWER CABLE BURNT. THE CONNECTOR WAS CHARRED, BUT THE POWER SUPPLY WAS OK. NO PT SAMPLES WERE LOST AND THERE WAS NO HARM TO THE PT. NO INJURIES, ANY VISIBLE FLAMES, OR SMOKE EMISSION WAS REPORTED NOT FIRE DEPARTMENT WAS CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE BOARD AND CABLE WERE BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524116 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1