BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE NEWPORT HT50 VENTILATOR

    MDR report key: 1301903 · Received January 30, 2009

    Report

    Report Number
    MW5009778
    Event Type
    Death
    Date Received
    January 30, 2009
    Date of Event
    January 19, 2009
    Report Date
    January 30, 2009
    Manufacturer
    FLIGHT MEDICAL, LOD, ISRAEL; EXCLUSIVELY FOR NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IN EARLY 2009, THE POWER AT MY CLIENT'S HOUSE WENT OUT FOR A FEW HOURS BEGINNING AT ABOUT 4:30 A.M. MY CLIENT WOKE UP AROUND 8:15 A.M. AND FOUND HER MOTHER LIFELESS. DURING THE POWER OUTAGE, THE INTERNAL BATTERY OF THE NEWPORT HT50 VENTILATOR NEVER SWITCHED TO ITS INTERNAL BATTERY AND THE INTERNAL ALARM NEVER SOUNDED TO INDICATE A PROBLEM. THE POWER WAS OUT FOR ONLY A FEW HOURS IN WHICH THE INTERNAL BATTERY SHOULD HAVE KICKED ON AND LASTED UNTIL THE POWER RETURNED. THE INTERNAL BATTERY IS SUPPOSED TO LAST 6-8 HOURS AND SOUND AN ALARM WHEN THE BATTERY IS LOW OR THERE IS A PROBLEM WITH THE MACHINE. MY CLIENT HAS EXPERIENCED PREVIOUS POWER OUTAGES WITH THE VENTILATOR AND DID NOT EXPERIENCE ANY PROBLEMS PREVIOUSLY. UNFORTUNATELY, WHEN MY CLIENT WOKE UP, HER MOTHER HAD ALREADY PASSED AWAY. IT HAS COME TO MY ATTENTION THAT THIS PARTICULAR DEVICE -THE NEWPORT HT50 VENTILATOR-ALL MODELS- WAS RECALLED BY THE FDA ON 31, 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE NEWPORT HT50 VENTILATOR VENTILATOR CBK FLIGHT MEDICAL, LOD, ISRAEL; EXCLUSIVELY FOR NEWPORT MEDICAL INSTRUMENTS, INC. HT50

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death