BEUDAMED
    FDA Adverse Event Summary report: N

    PK7300 AUTOMATED MICROPLATE SYSTEM

    MDR report key: 2140010 · Received June 25, 2011

    Report

    Report Number
    2050012-2010-02639
    Date Received
    June 25, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    KSZ
    PMA / PMN Number
    BK060024
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FSE REPLACED PCB ((B)(4)) AND CALIBRATED ALL PRESSURES. FSE VERIFIED REPAIRS PER ESTABLISHED PROCEDURES. THE SYSTEM OPERATIONAL. ACCEPTABLE RESULTS OBTAINED FROM CUSTOMER POST-SERVICE VERIFICATION TEST RUN. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) FIELD SERVICE ENGINEER (FSE) REPORTED A BURNING SMELL WITHOUT SMOKE ON THE PK7300 AUTOMATED MICROPLATE SYSTEM. THE SMELL WAS ASSOCIATED WITH A SHORTED PRINTED CIRCUIT BOARD (PCB PART NUMBER MU7161). NO REPORTS OF DEATH OR INJURY ASSOCIATED WITH THIS EVENT. THIS EVENT DID NOT AFFECT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK7300 AUTOMATED MICROPLATE SYSTEM AUTOMATED MICROPLATE SYSTEM KSZ BECKMAN COULTER MISHIMA K.K. PK7312-02 W/OSV N/A

    Patients

    Seq Age Sex Outcome Treatment
    1