BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYGROLIFE II

    MDR report key: 1318364 · Received February 18, 2009

    Report

    Report Number
    2936999-2009-00044
    Event Type
    Death
    Date Received
    February 18, 2009
    Date of Event
    January 21, 2009
    Report Date
    January 21, 2009
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYGROLIFE HME WAS DISCARDED AND THEREFORE UNAVAILABLE FOR FAILURE INVESTIGATION. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. THE LOT NUMBER WAS PROVIDED AND THE MANUFACTURER WILL REVIEW THE LOT HISTORY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIANS IN THE INTENSIVE CARE UNIT DISCOVERED THAT THE VENTILATOR SHOWED THE WARNING ALARM WITH HIGH PRESSURE AND THE HME WAS TOO WET WITH HIGH RESISTANCE. IT WAS REPORTED THAT THE PT SHOWED CYANOSIS. IT WAS REPORTED THAT THE PT HAD EXPIRED AFTER CPR. THE PHYSICIANS WERE NOT SURE THAT THE EVENT WAS CAUSED BY VENTILATOR OR HME. THE DEFECTIVE HME WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYGROLIFE II NONE BZO COVIDIEN/FORMERLY TYCO HEALTHCARE 0805001816

    Patients

    Seq Age Sex Outcome Treatment
    1 Death