BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7342876 · Received March 15, 2018

    Report

    Report Number
    8010042-2018-00143
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 23, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PATIENT CASSETTE INCLUDING THE ALLEGEDLY STUCK ONE WAY VALVES HAS BEEN TESTED AND THERE WERE NO INDICATIONS OF STUCK VALVES. THE PATIENT CASSETTE FUNCTIONS AS INTENDED. ACCORDING TO THE TEST LOG, A SUCCESSFUL SYSTEM CHECK OUT (SCO) WAS PERFORMED JUST PRIOR TO THE EVENT. THERE IS NO RECORDED SCO AFTER THE EVENT. BOTH THE TREND LOG AND THE INTERNAL LOG SHOW THAT THERE WERE DIFFICULTIES TO VENTILATE THE PATIENT. THERE WERE ALARMS INDICATING A LEAKAGE. BASED ON THE LACK OF TECHNICAL ALARMS RELATED TO PRESSURE AND THE LACK OF NEGATIVE PRESSURES RECORDED IN THE TREND LOG, IT IS NOT LIKELY THAT A STUCK INSPIRATORY AND/OR INSPIRATORY VALVE CONTRIBUTED TO THE REPORTED EVENT. BASED OF THE ABOVE INFORMATION, WE ARE UNABLE TO DETERMINE THE ROOT-CAUSE OF THE REPORTED PROBLEM. 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 PERSON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSPIRATORY AND EXPIRATORY VALVES IN THE PATIENT CASSETTE WERE STUCK IN CLOSED POSITION DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183446 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1