BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY ANALYZER

    MDR report key: 94893 · Received June 2, 1997

    Report

    Report Number
    MW1011376
    Event Type
    Malfunction
    Date Received
    June 2, 1997
    Date of Event
    May 13, 1997
    Report Date
    May 23, 1997
    Manufacturer
    DADE INT'L INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAB TECH REPORTED SMOKE POURING OUT OF CHEMISTRY ANALYZER. MFR REP CAME IN FOR EVALUATION AND REPLACED CRT & CONTROL BOARD. NO INJURY TO STAFF OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJC DADE INT'L INC. ACA IV *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other