BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON-C2

    MDR report key: 3652497 · Received February 26, 2014

    Report

    Report Number
    3652497
    Event Type
    Death
    Date Received
    February 26, 2014
    Date of Event
    February 23, 2014
    Report Date
    February 26, 2014
    Manufacturer
    HAMILTON MEDICAL
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A COMPLICATED ADMISSION WITH MANY COMORBIDITIES, BUT HAD BEGUN TO STABILIZE ON THE VENTILATOR. WHILE ON THE VENTILATOR, THE PATIENT'S RETURN VOLUME FELL SHARPLY AND THE PATIENT DECOMPENSATED. THE PATIENT WAS IMMEDIATELY BAGGED AND THE PATIENT'S RETURN VOLUME WAS QUICKLY NORMALIZED. THE PATIENT NEVER RECOVERED FROM THE EVENT AND THE PATIENT PASSED WITHIN 24 HOURS. THE VENTILATOR WAS INVESTIGATED BY THE BIO-MEDICAL TEAM AND NOTHING ABNORMAL WAS DISCOVERED ON THE LOG REPORT. THE VENTILATOR WAS TESTED AND WORKED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117391 HAMILTON-C2 VENTILATOR, CONTINUOUS, FACILITY USE CBK HAMILTON MEDICAL C2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death