BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXICAIR ECLIPSE

    MDR report key: 1442811 · Received May 15, 2009

    Report

    Report Number
    1045510-2009-00009
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    April 16, 2009
    Report Date
    May 15, 2009
    Manufacturer
    HILL-ROM CHARLESTON
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT THAT FLEXICAIR ECLIPSE LOW AIR LOSS THERAPY DEVICE WAS EMITTING SMOKE. A HILL-ROM TECHNICIAN INVESTIGATED THE DEVICE AND DETERMINED THE PROBLEM ORIGINATES FROM THE INTERFACE BETWEEN THE AC INLET FILTER AND POWER CORD. THE POWER CORD AND THE AC INLET FILTER WERE ANALYZED BY HILL-ROM ENGINEERING AND IT WAS DETERMINED THERE WERE A NUMBER OF POTENTIAL ROOT CAUSES. IT WAS OBSERVED THAT THE POWER CORD WAS NOT FULLY INSERTED IN THE AC FILTER, POTENTIALLY LEADING TO A POOR CONNECTION AND RESISTANCE. IN ADDITION, ENGINEERING NOTED THE AC INLET FILTER MAY HAVE BEEN AFFECTED BY REPEATED CLEANING CYCLES, WHICH MAY HAVE ALSO CONTRIBUTED TO THE EVENT. CLEANING AGENTS CAN BUILD UP ON THE CONTACTS OF THE AC INLET FILTER ALSO CAUSING A POOR CONNECTION AND RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAIR ECLIPSE BED, FLOTATION THERAPY, POWERED IOQ HILL-ROM CHARLESTON I4500

    Patients

    Seq Age Sex Outcome Treatment
    1