BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN IRIS STATSPIN

    MDR report key: 3820383 · Received May 13, 2014

    Report

    Report Number
    MW5036138
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    March 5, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BECKMAN IRIS STATSPIN MODEL M510 EXPRESS4 CENTRIFUGE'S ROTOR SHATTERED DURING OPERATION ON (B)(6) 2014. TWO OTHER EVENTS WITHIN (B)(6) HEALTHCARE HAPPENED WITH THE SAME PRODUCT; ON (B)(6) 2014. SPECIMENS LOST, NO OPERATOR INJURY REPORTED. COMPLAINT FILED WITH MFR OBTAINED REF. # (B)(4). BROKEN ROTOR TO CENTRIFUGE WHILE IN OPERATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287461 BECKMAN IRIS STATSPIN BECKMAN IRIS STATSPIN GKG BECKMAN COULTER M510 EXPRESS4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other