BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J2-HS CENTRIFUGE

    MDR report key: 2128419 · Received June 16, 2011

    Report

    Report Number
    2050012-2011-02273
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED AND THE FIELD SERVICE ENGINEER (FSE) REPLACED THE HAND LATCH INTERLOCK ASSEMBLY, WHICH HAD FAILED. REPETITIVE ATTEMPTS AT OPENING THE CENTRIFUGE DOOR WHILE THE DOOR LATCH WAS ENGAGED CAUSED TO LATCH HANDLE TO ULTIMATELY BEND AND BECOME INOPERABLE. RECURRING CUSTOMER TRAINING AND SIGNAGE HAD PREVIOUSLY BEEN APPLIED TO THE DEVICE TO ATTEMPT TO REDUCE THIS USE ERROR. THE INSTRUMENT INVOLVED IN THIS EVENT IS NOT CLASSIFIED AS A MEDICAL DEVICE BY THE FOOD & DRUG ADMINISTRATION. HOWEVER, THE INTERLOCK ASSEMBLY INVOLVED WITH THIS EVENT IS UTILIZED ON THE FOLLOWING BECKMAN COULTER INC. MEDICAL DEVICES: J6-MI CENTRIFUGE PRODUCT NUMBER (B)(4). J6-MI CENTRIFUGE PRODUCT NUMBER(B)(4). J6-MI CENTRIFUGE PRODUCT NUMBER (B)(4). J6-MI CENTRIFUGE PRODUCT NUMBER (B)(4). J6-MI CENTRIFUGE PRODUCT NUMBER (B)(4). J6-MI CENTRIFUGE PRODUCT NUMBER (B)(4). THESE DEVICES POSSESS PRODUCT CLASSIFICATIONS OF JQC, CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE AND ARE 510K CLASS I EXEMPT DEVICES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE ABLE TO OPEN THE DOOR OF A J2-HS ENCORE CENTRIFUGE WHILE THE ROTOR WAS STILL SPINNING. THERE WAS NO PERSONNEL CONTACT WITH THE ROTOR. THERE WERE NO DEATHS OR SERIOUS INJURIES ASSOCIATED WITH THIS EVENT. NO ONE REQUIRED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J2-HS CENTRIFUGE NOT A MEDICAL DEVICE JQC BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1