BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLENNIUM M10

    MDR report key: 7446358 · Received April 19, 2018

    Report

    Report Number
    MW5076572
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    April 10, 2018
    Report Date
    April 17, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    OXYGEN CONCENTRATOR FAILURE. THE UNIT FAILED FROM A LOOSE WATER BOTTLE AND MY WIFE WENT TO THE ER AND SPENT TWO DAYS IN THE HOSPITAL. SO FAR I HAVE FOUND THREE PROBLEMS WITH THESE UNITS: THEY MAY NOT DETECT COMMERCIAL POWER FAILURE; THEY MAY NOT DETECT A LOOSE WATER BOTTLE; THEY DO NOT DETECT A LACK OF AIR TO THE PT. SO FAR I HAVE CONTACTED THREE MRS AND ONLY ONE COVERS TWO (1 AND 2) OF THESE PROBLEMS. A REHAB FACILITY USES THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286819 MILLENNIUM M10 GENERATOR, OXYGEN, PORTABLE CAW PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization