BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 4040337 · Received August 22, 2014

    Report

    Report Number
    2021710-2014-00044
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE BY THE USER FACILITY IS A SUMMARY OF THE INFO DOCUMENTED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. THE USER FACILITY BIOMED EVALUATED THE DEVICE AND WAS NOT ABLE TO REPRODUCE THE REPORTED EVENT THUS WAS NOT ABLE TO IDENTIFY ROOT CAUSE IN THIS ALLEGED EVENT. IN ADDITION THE USER FACILITY RESPIRATORY THERAPIST REPORTED THAT THE DEVICE IS OPERATING FINE AND WAS PLACED BACK INTO SERVICE. AS OF (B)(4) 2014 THE USER FACILITY HAS NOT REQUESTED ADDITIONAL REPORT TO CAREFUSION ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A (B)(4) REPORT RECEIVED BY CAREFUSION FROM THE FDA (B)(4) 2014. THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP ON (B)(4) 2014. "THE EVENT WAS ON A PT JUST BEING ADMITTED AND THEN PT WAS PUT INTO ANOTHER VENT WITHOUT INJURY. THE VENT DID ALARM WHEN IT SHUT DOWN AND ALSO HE SAID IT WAS PLUGGED INTO AC POWER. [NAME REMOVED] SAID THEY WERE UNABLE TO DUPLICATE THE VENT LOSING POWER AND THAT IT IS WORKING FINE NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508560 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA COMP D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention