BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSZ

    MDR report key: 3804831 · Received April 7, 2014

    Report

    Report Number
    3010587095-2014-00006
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Report Date
    March 4, 2014
    Manufacturer
    PHILIPS ANESTHESIA CARE
    Product Code
    BSZ
    PMA / PMN Number
    K122063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NOTE THAT MANUAL DELIVERY IS AVAILABLE IF NEEDED, SUCH AS IF THERE WOULD BE NO AUTOMATED AIR FLOW; MANUAL DELIVERY IS A NORMAL PART OF THE USE FOR EVERY PT; AND THE IFU FOR THIS DEVICE SPECIFIES THAT THERE BE AN ATTENDANT CLINICIAN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A USER REPORTED NO FLOW FROM THE MACHINE EVEN IN EMERGENCY FRESH GAS FLOW. THERE WAS NO ADVERSE IMPACT ON THE PT. WE DO NOT KNOW WHETHER THE CLINICIAN MAY NEED TO SWITCH TO MANUAL DELIVERY OR CHANGE ANESTHESIA SYSTEM IF THIS WERE TO RECUR. THIS PROBLEM OCCURRED DURING THE FIRST USES OF THIS DEVICE AND HAS NOT RECURRED SINCE THE USERS HAVE BECOME MORE EXPERIENCED. THE DEVICE REMAINS IN USE AND HAS NEEDED NO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207733 BSZ DAMECA, GAS-MACHINE, ANESTHESIA BSZ PHILIPS ANESTHESIA CARE 866205

    Patients

    Seq Age Sex Outcome Treatment
    1