BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN EXPRESS 4 CENTRIFUGE

    MDR report key: 3750501 · Received January 31, 2014

    Report

    Report Number
    2023446-2014-00002
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    October 17, 2013
    Report Date
    October 17, 2013
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THE LATCH FOR THE LID ON THE STATSPIN CENTRIFUGE WAS BROKEN. THE UNIT WAS NOT ON NOR WAS IT RUNNING WHEN THE LATCH WAS BROKEN. NO INJURIES REPORTED.

    Description of Event or Problem · 1

    CUSTOMER STATED THE LATCH ON THE UNIT IS BROKEN. NO INJURIES TO USER OR PT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67401 STATSPIN EXPRESS 4 CENTRIFUGE STATSPIN EXPRESS 4 JQC IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1