BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER HANNIFAN (PORTER) MEDICAL REGULATOR

    MDR report key: 6884328 · Received September 21, 2017

    Report

    Report Number
    1044295-2017-00001
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Report Date
    September 14, 2017
    Manufacturer
    HARRIS PRODUCTS GROUP
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN NOTIFIED BY PARKER HANNIFAN (PORTER) VERBALLY DURING A CUSTOMER VISIT OF THE FOLLOWING FACTS. APPROXIMATELY 3 MONTHS AGO IN A HOSPITAL, AN OXYGEN PRESSURE REGULATOR ALLEGEDLY FAILED, WHICH THEN RESULTED IN AN OXYGEN FIRE. THE OXYGEN PRESSURE REGULATOR IS A COMPONENT OF THE MANIFOLD ASSEMBLED BY PARKER HANNIFAN (PORTER) IN 2013. PRIOR TO THE INCIDENT, THE MANIFOLD WAS REPORTED TO HAVE LOW FLOW, AND THEN THE MANIFOLD WAS TAKEN OUT OF SERVICE. THE TECHNICIAN WORKING ON THE MANIFOLD NOTED THAT THE REGULATORS WERE MAKING A CLICKING NOISE. THE TECHNICIAN THEN TURNED OFF THE OXYGEN AND TURNED IT BACK ON. AT THAT POINT, THE OXYGEN PRESSURE REGULATOR CAUGHT FIRE. THE TECHNICIAN'S ARM WAS ALLEGEDLY INJURED FROM THE FIRE, ALTHOUGH WE DO NOT KNOW THE NATURE OF THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664234 PARKER HANNIFAN (PORTER) MEDICAL REGULATOR OXYGEN PRESSURE REGULATOR CAN HARRIS PRODUCTS GROUP REG, 301-50P 7010-1

    Patients

    Seq Age Sex Outcome Treatment
    1