BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 8478110 · Received April 3, 2019

    Report

    Report Number
    8010042-2019-00236
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 26, 2019
    Report Date
    October 31, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ANESTHESIA WORKSTATION WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER. THE INSPIRATORY PRESSURE TRANSDUCER PCB, FRESH GAS PRESSURE TRANSDUCER AND O2 FRESH GAS MODULE WERE FOUND FAULTY AND WAS REPLACED. AFTER THIS THE SYSTEM CHECKOUT PASSED WITHOUT DEVIATIONS. NO PARTS WERE RETURNED. EVALUATION OF THE RECEIVED DEVICE LOG CONFIRM THAT THE SYSTEM CHECKOUT FAILED. THE PRESSURE TRANSDUCER TEST FAILED DUE TO THE MEASURED GAIN CORRECTION FACTOR FOR THE INSPIRATORY PRESSURE TRANSDUCER BEING OUTSIDE ALLOWED LIMITS. ALSO THE FLOW TRANSDUCER TEST, THE MANUAL VENTILATION LEAKAGE TEST AND THE VAPORIZER INLET/OUTLET VALVE TEST FAILED. THE ROOT CAUSE OF THE REPORTED SYSTEM CHECKOUT FAILURES CANNOT BE DETERMINED AS NO PARTS WERE RETURNED FOR INVESTIGATION. HOWEVER, BASED ON THAT THE SYSTEM CHECKOUT PASSED WITHOUT DEVIATIONS AFTER REPLACEMENT OF THE ABOVE PARTS THE CONCLUSION IS THAT THESE PARTS WERE FAULTY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION FAILED THE PRESSURE TRANSDUCER TEST DURING SYSTEM CHECK OUT. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF #:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273413 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1