BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 3957277 · Received June 17, 2014

    Report

    Report Number
    2023446-2014-00073
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE EXPRESS 4 UNIT WAS INOPERABLE. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE INTERCONNECT CABLE TO THE BOARD SHOWED SIGNS OF BEING BURNT. THERE WERE NO REPORTS OF INJURIES, NO VISIBLE FLAMES, SMOKE, OR FIRE DEPT CALLED. THE UNIT WAS REPAIRED AND SENT BACK.

    Description of Event or Problem · 1

    CUSTOMER STATES THE EXPRESS 4 UNIT HAD NO POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354451 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1