BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4911739 · Received July 10, 2015

    Report

    Report Number
    2021710-2015-01193
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 11, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT PRESENT, NO DEVICE HAS BEEN RETURNED. CAREFUSION IS CURRENTLY WORKING WITH THE FOREIGN DISTRIBUTOR TO BETTER UNDERSTAND THIS EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A WARRANTY CLAIM FORM SUBMITTED BY THE FOREIGN DISTRIBUTOR IN (B)(6). "ON CPAP MODE, APNEA INTERVAL GOES OFF EVEN THE PATIENT HAS SPONTANEOUS BREATH. THE CIRCUIT DISCONNECT OFTEN GOES OFTEN GOES OFF OTHER VENTILATION MODE WITH NO LEAK CIRCUMSTANCE. THE ISSUE GOES AWAY TO INCREASE TRIGGER SENSITIVITY SOMETIMES, BUT NOT FOR ALL PATIENT." ADDITIONALLY, THE DISTRIBUTOR REPORTED THAT THE UNIT HAD AN APNEA INTERVAL AND CIRCUIT DISCONNECT ALARM. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448642 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MR850 HUMIDIFIER.| RT380 EVAQUA2 DUAL LIMB PT CIRCUIT FISHER PYKEL.