BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 4071901 · Received August 12, 2014

    Report

    Report Number
    2023446-2014-00117
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 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 THE EXPRESS 4 POWER HARNESS HAD EVIDENCE OF CHARRED MATERIAL. NO INJURIES, OPEN FLAMES, OR SMOKE WAS REPORTED, NOR FIRE DEPARTMENT BEING CALLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FAULTY POWER INTERCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479038 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1