BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 3030618 · Received March 22, 2013

    Report

    Report Number
    2031702-2013-00049
    Event Type
    Injury
    Date Received
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DID NOT HAVE AN AUDIBLE/VISIBLE ALARM WHEN THE PATIENT CIRCUIT WAS DISCONNECTED FROM THE PATIENT. THE NURSE WAS ALERTED BY THE ALARM ON THE SPO2 MONITOR. THE NURSE RECONNECTED THE PATIENT TO THE CIRCUIT AND HYPER-OXYGENATED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119177 LTV VENTILATOR, CONTINOUS / CBK CBK CAREFUSION 203, INC ENVE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention