BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMAX ANALYTICAL SYSTEM MONITOR

    MDR report key: 107025 · Received July 22, 1997

    Report

    Report Number
    2023780-1997-00002
    Event Type
    Malfunction
    Date Received
    July 22, 1997
    Date of Event
    July 5, 1997
    Report Date
    July 21, 1997
    Manufacturer
    DADE INTL., INC.
    Product Code
    JJC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LABORATORY EMPLOYEE RECEIVED AN ELECTRICAL SHOCK WHILE RESETTING THE INSTRUMENT SYSTEM VT TERMINAL. EMPLOYEE WENT TO THE HOSP EMERGENCY ROOM FOR OBSERVATION WITH A LOW HEART RATE. EVALUATION OF THE TERMINAL BY THE HOSP BIO MED DEPT LATER THAT DAY DID NOT IDENTIFY ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMAX ANALYTICAL SYSTEM MONITOR CLINICAL CHEMISTRY ANALYZER TOUCH MONITOR JJC DADE INTL., INC. 720 ZX TOUCH MONITOR (CT220) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other