BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN SSVT-1 CENTRIFUGE

    MDR report key: 5106034 · Received September 25, 2015

    Report

    Report Number
    2023446-2015-00239
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    FA-24395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPONENTS HAVE BEEN RETURNED TO THE MANUFACTURER. NO FURTHER INVESTIGATION MAY BE CARRIED OUT. THE CUSTOMER WILL BE SUPPLIED WITH A NEW CENTRIFUGE ROTOR. THE BECKMAN COULTER (BEC) INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4)..

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE RT12 ROTOR BROKE APART IN THEIR STATSPIN SSVT-1 CENTRIFUGE DURING OPERATION. THE CUSTOMER INDICATED SHIELD WAS IN PLACE AT THE TIME OF FAILURE. THERE WAS NO REPORT OF ESCAPE OF PARTS FROM CENTRIFUGE AT THE TIME OF FAILURE. THERE WAS NO REPORT OF HARM OR EXPOSURE TO OPERATORS; OR INJURY TO (VETERINARY) PATIENTS AT THE TIME OF THE FAILURE. THE ROTOR FAILURE WAS ALSO ASSOCIATED WITH DISCONNECTION OF THE ROTOR HUB FROM THE DRIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635406 STATSPIN SSVT-1 CENTRIFUGE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC IRIS INTERNATIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1