BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIBATCH 10 BW

    MDR report key: 304201 · Received November 9, 2000

    Report

    Report Number
    304201
    Event Type
    Malfunction
    Date Received
    November 9, 2000
    Date of Event
    October 30, 2000
    Report Date
    November 8, 2000
    Manufacturer
    X-RITE
    Product Code
    IXW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXPOSED TO CHEMICAL FUMES EMITTED FROM EQUIPMENT THAT MALFUNCTIONED IN A DARKROOM IN THE RADIOLOGY DEPT. SYMPTOMS INCLUDED HEADACHE AND RASH. REMOVED EQUIPMENT FROM HOSP. ODOR DISSIPATED. SULFUR GAS EMITTED. AIR TESTED FOR H2S, RESULTS NEGATIVE. EMPLOYEE BECAME A PT SEEN IN E.R. TREATED & RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIBATCH 10 BW SAFETY KLEEN SILVER RECOVERY UNIT IXW X-RITE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other