BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100A VENTILATOR

    MDR report key: 5347340 · Received January 6, 2016

    Report

    Report Number
    2021710-2016-02638
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    December 11, 2015
    Report Date
    December 11, 2015
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION FILE IDENTIFICATION NUMBER IS (B)(4). ANY ADDITIONAL INFORMATION THAT IS PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE COMPONENT FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED START/STOP BUTTON WAS NOT WORKING WHEN PUSHED TO START. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT OR ALLEGATION OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6610 3100A VENTILATOR VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1