BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C30

    MDR report key: 6085373 · Received November 8, 2016

    Report

    Report Number
    8010042-2016-00509
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 25, 2016
    Report Date
    February 8, 2017
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K133958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR COMPANY FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE ANESTHESIA WORKSTATION AT THE HOSPITAL. NO FAULT WAS FOUND, HOWEVER THE REPORTED ISSUE COULD BE REPRODUCED BY SLIGHTLY LOOSENING THE GAS ANALYZER WATER TRAP. SIMULATED-USE TESTING WAS PERFORMED AND NO DEVIATIONS OR DAMAGE WAS NOTICED. AS A RESULT, NO PARTS NEEDED TO BE REPLACED. A SUCCESSFUL SYSTEM CHECK-OUT AND FUNCTIONAL TESTS WERE PERFORMED AND THE ANESTHESIA WORKSTATION WAS THEN RETURNED TO SERVICE. THE DEVICE LOGS WERE SENT IN FOR EVALUATION, AND THE REPORTED O2 CONCENTRATION ISSUES WERE CONFIRMED IN THE DEVICES' EVENT LOG. THE TECHNICAL LOG DID NOT CONTAIN ANY LOG POSTS WHICH INDICATED THAT THERE WERE ANY TECHNICAL MALFUNCTIONS AT THE TIME OF THE EVENT. A SUCCESSFUL SYSTEM CHECK-OUT TEST WAS PERFORMED IMMEDIATELY BEFORE STARTING THE CASE, IN WHICH THE ISSUES OCCURRED. BASED ON THE FINDINGS STATED ABOVE, OUR CONCLUSION IS THAT THE GAS ANALYZER SAMPLING LINE WAS SLIGHTLY LOOSE DURING THE EVENT, RESULTING IN ROOM AIR BEING SAMPLED, WHICH LED TO A LOWER MEASURED FIO2 CONCENTRATION AND THE GENERATION OF ALARMS.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE ANESTHESIA WORKSTATION DISPLAYED O2 CONCENTRATION LEVELS OF APPROXIMATELY 20-30% WHEN, THE SET VALUES WERE 80-100%. THERE WAS NO PATIENT HARM REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736375 FLOW-I C30 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C30

    Patients

    Seq Age Sex Outcome Treatment
    1