BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY

    MDR report key: 2512535 · Received March 21, 2012

    Report

    Report Number
    2512535
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 23, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE DEVICE WAS ON PATIENT, VENTILATOR INDICATED THERE WAS A DEVICE ERROR (FUNCTION 3). PATIENT REMOVED FROM DEVICE AND MANUALLY BAGGED WHILE NEW VENTILATOR WAS SET UP ON PATIENT.======================MANUFACTURER RESPONSE FOR VENTILATOR, DRAGER (PER SITE REPORTER).======================DRAGER TSR IN TO SERVICE VENT. C500 REPLACED. AWAITING SO AT THIS TIME BUT TSR HAS RELEASED VENT BACK TO SERVICE. VENT RTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA INFINITY VENTILATOR CBK DRAEGER MEDICAL GMBH V500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR