BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSZ

    MDR report key: 4184667 · Received August 13, 2014

    Report

    Report Number
    3010587095-2014-00012
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Report Date
    July 21, 2014
    Manufacturer
    PHILIPS ANESTHESIA CARE
    Product Code
    BSZ
    PMA / PMN Number
    K122063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A USER REPORTED "O2, AIR/N2O FRESH GAS OUT OF CONTROL" ALARM. IT IS NOT SPECIFICALLY REPORTED WHICH OF THE THREE GASSES HAD AN ACTUAL PROBLEM/CAUSED THE ALARM. THE ALARM MESSAGES ARE SPECIFIC TO THE GAS SUPPLY RELATED TO THE CONDITION OUTSIDE NORMAL AND EXPECTED. THROUGH THE LOCAL FIELD SERVICE ENGINEER, PHILIPS HAS VERIFIED THAT THIS ISSUE OCCURRED AFTER THE SELF-TEST HAD BEEN BY-PASSED, BUT NOT DURING USE ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482777 BSZ DAMECA, GAS-MACHINE, ANESTHESIA BSZ PHILIPS ANESTHESIA CARE 866205

    Patients

    Seq Age Sex Outcome Treatment
    1