BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 5001657 · Received August 11, 2015

    Report

    Report Number
    2021710-2015-01380
    Event Type
    Death
    Date Received
    August 11, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 17, 2015
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAREFUSION FAILURE ANALYSIS TECHNICIAN WILL EVALUATE THE ALLEGED FAILED PRODUCT IF IT IS RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE IN PATIENT USE THE VENTILATOR SUDDENLY SHUT DOWN. CONFIRMED BY THE DOCTOR ON DUTY, WHO WAS IN THE ROOM NEXT TO THE PATIENT BED THAT HE DID NOT HEAR ANY SOUND ALARM SIGNAL, THOUGH THE ALARM SIGNAL USED TO BE VERY LOUD, ESPECIALLY DURING NIGHT TIME. THE NURSE ON DUTY CONFIRMED NO SOUND ALARM SIGNAL GENERATED WHEN THE PISTON STOPPED. THE PATIENT WAS PLACED ON CONVENTIONAL CMV AND LATER DIED DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525174 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death MOTOR PHILLIP: MEASURE SPO2