BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HLD TROPHON

    MDR report key: 6311528 · Received February 7, 2017

    Report

    Report Number
    MW5067737
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    February 1, 2017
    Report Date
    February 7, 2017
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    OUJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE GE HLD TROPHON DEVICE IS USED ON THE L AND D UNIT FOR DISINFECTING PROBES. THE 35 PERCENT HYDROGEN PEROXIDE SOLUTION WAS NOTED TO HAVE LEAKED ONTO THE COUNTERTOP AND FLOOR. THE NURSE DID NOT NOTICE UNTIL IT SOAKED THROUGH HER PANT LEG AND BECAME BUBBLY RED, THEN WHITE. AFTER TOUCHING HER PANT LEG AND COUNTERTOP WITH HER HAND, THE NURSE FELT THE BURNING. SHE IMMEDIATELY NOTIFIED THE CHARGE NURSE AND THE MANUFACTURER WAS CONTACTED. APPROPRIATE ACTION WAS TAKEN. FOUR NURSES AND PCT'S WERE EXPOSED BY DIRECT CONTACT AND/OR BY THE FUMES TO THE H2O2 CHEMICAL. THEY WERE EVALUATED BY OCCUPATIONAL HEALTH AS PER THE RECOMMENDATION OF THE MANUFACTURER. EVENT: 4 OZ CONTAINER OF 35 PERCENT SOLUTION OF HYDROGEN PEROXIDE LEAKED ONTO COUNTER TOP AND FLOOR; NEW HDL SUPPLIED TO THE UNIT. HDL UNIT INVOLVED IN EVENT RETURNED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89122 GE HLD TROPHON TROPHON HIGH LEVEL DISINFECTOR OUJ GE MEDICAL SYSTEMS N00010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention