BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7942988 · Received October 8, 2018

    Report

    Report Number
    8010042-2018-00529
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    May 10, 2018
    Report Date
    May 22, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 (B)(4). CONTACT PERON: (B)(4). OUR FIELD SERVICE ENGINEER CONFIRMED THE FAULT DURING ON-SITE INVESTIGATION. THE AIR GAS MODULE WAS FOUND FAULTY AND WAS REPLACED. THE RETURNED AIR GAS MODULE WAS SIMULATED USE TESTED IN A REFERENCE ANESTHESIA SYSTEM. THE REPORTED FAULT COULD BE REPRODUCED. FURTHER INVESTIGATIONS REVEALED THAT THE CAUSE OF THE REPORTED ISSUES WAS A FAULTY DELTA PRESSURE SENSOR LOCATED INSIDE THE RETURNED AIR GAS MODULE. EVALUATION OF THE RECEIVED DEVICE TREND LOG, THE EVENT LOG AND THE TEST LOG CONFIRM THE REPORTED ISSUES. THE AIR GAS MODULE DELIVERED A HIGHER FLOW THAN EXPECTED. THIS LED TO AN INCREASED LEVEL OF AIR IN THE GAS MIX (AND DECREASED LEVEL OF O2). AN INCREASED FLOW FROM THE AIR GAS MODULE ALSO INCREASED THE PRESSURE IN THE FRESH GAS LINE LEADING TO THE PATIENT. ALARMS SUCH AS AIRWAY PRESSURE: HIGH, FIO2 LOW AND RR: HIGH WERE GENERATED. THE ALARM AIRWAY PRESSURE: HIGH WILL LEAD TO THE ACTIVATION OF THE FRESH GAS SAFETY VALVE (OPENING) AND WILL AUTOMATICALLY FORCE THE SYSTEM INTO ITS EXPIRATORY STATE, TO AVOID OVER-PRESSURE SITUATIONS. OUR CONCLUSION IS THAT A DELTA PRESSURE SENSOR IN THE AIR GAS MODULE WAS THE CAUSE OF THE REPORTED FAILURE. THE ROOT CAUSE OF THE PRESSURE SENSOR FAILURE HAS NOT BEEN DETERMINED.

    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).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THERE WERE SUDDEN LOUD NOISES FROM THE ANESTHESIA WORKSTATION LEADING TO OPENING OF THE FRESH GAS SAFETY VALVE AND ALARMS FOR HIGH AIRWAY PRESSURE. THERE WAS NO PATIENT HARM REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784842 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1