BEUDAMED
    FDA Adverse Event Death Summary report: N

    VELA VENTILATOR

    MDR report key: 17516361 · Received August 11, 2023

    Report

    Report Number
    MW5123310
    Event Type
    Death
    Date Received
    August 11, 2023
    Report Date
    August 9, 2016
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS IS TO INFORM YOU THAT GE HEALTHCARE RECEIVED A COMPLAINT FROM (B)(6) WHERE A PATIENT DEATH WAS REPORTED. AFTER FURTHER CLARIFICATIONS WITH THE CUSTOMER, IT WAS CONFIRMED THAT A MALFUNCTION OF A CAREFUSION VELA? VENTILATOR WHICH IS NOT MANUFACTURED, IMPORTED, OR DISTRIBUTED BY GE HEALTHCARE, MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ADVERSE EVENT. THIS PRODUCT IS OWNED BY CAREFUSION. GE HEALTHCARE MEDICAL SYSTEM FUNCTIONED PER GE HEALTHCARE SPECIFICATION AND NO SYSTEM MALFUNCTION WAS REPORTED. PLEASE SEE THE COMPLAINT INFORMATION BELOW FOR ADDITIONAL DETAILS: CUSTOMER NAME: (B)(6) HOSPITAL. CUSTOMER ADDRESS: (B)(6). CUSTOMER PHONE NUMBER: (B)(6). PRODUCT NAME: CAREFUSION VELA? VENTILATOR A CAREFUSION VELA? VENTILATOR CONNECTED TO A NURSE CALL SYSTEM, FAILED TO ALARM WHILE ACTIVELY MONITORING A PATIENT. THE PATIENT DIED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192587 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown