BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS 4

    MDR report key: 3886270 · Received April 9, 2014

    Report

    Report Number
    2023446-2014-00037
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    IRIS INTERNATIONAL
    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

    STATSPIN CENTRIFUGE UNIT WAS NOT WORKING AND THE CABLE BETWEEN POWER SUPPLY AND PCB BOARD WAS MELTED. NO INJURIES WERE REPORTED. NO VISIBLE FLAMES AND SMOKE WERE OBSERVED, NOR FIRE DEPARTMENT WAS CALLED. HOWEVER, THERE WAS EVIDENCE OF CHARRED MATERIAL. THE UNIT EVALUATION UPON SERVICE SHOWED POWER HARNESS MELTED TO THE PCB. THE PCB WAS REPLACED AND OTHER PARTS REBUILT TO BRING UNIT UP TO CURRENT SAFETY STANDARDS.

    Description of Event or Problem · 1

    CUSTOMER NOTED THE CABLE BETWEEN THE POWER SUPPLY AND BOARD WAS MELTED AT THE CONNECTION TO THE BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215999 EXPRESS 4 STATSPIN CENTRIFUGE JQC IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1