BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO GUARD

    MDR report key: 4202581 · Received September 18, 2014

    Report

    Report Number
    8010042-2014-00400
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CAH
    PMA / PMN Number
    K030071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER DISPATCHED TO THE SITE EXAMINED THE VENTILATOR AND DOWNLOADED THE LOGS. NO MALFUNCTION WAS DETECTED AND NO PARTS WERE EXCHANGED. ADDITIONAL INFO RECEIVED FROM THE HOSPITAL STATES THAT A SINGLE USE BIDIRECTIONAL BACTERIAL/VITAL FILTER WAS CONNECTED IN THE PT CIRCUIT AND HAD BEEN IN USE FOR 12 HOURS AND THAT THE PT WAS BEING MEDICATED VIA NEBULIZATION DURING THAT TIME. THE FILTER MUST BE REPLACED EVERY 24 HOURS OR IF THE EXPIRATORY RESISTANCE INCREASE WHICHEVER COMES FIRST. THE VENTILATOR'S LOGS CONTAIN ALARMS THAT INDICATE HIGH EXPIRATION PRESSURE. THESE ALARMS IN THE MODE OF VENTILATION AT THE TIME IMPLY THE DELIVERED TIDAL VOLUMES WERE LOWER THAN THE PRE-SET TIDAL VOLUMES AND MAY BE EXPERIENCED AS THE VENTILATOR NOT DELIVERING ADEQUATE TIDAL VOLUMES AS WAS REPORTED. THE LOGS DO NOT CONTAIN TECHNICAL ALARMS TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION AT THE TIME. THE FILTER HAS NOT BEEN INVESTIGATED, BUT THE CONCLUSION IN THE MATTER BASED ON THE AVAILABLE INFO IS THAT THE CAUSE OF THE EVENT WAS A CLOGGED FILTER. THE VENTILATOR ONTO WHICH THE FILTER WAS CONNECTED ALARMED FOR THE SITUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT IT DID NOT DELIVER THE PROPER VOLUME NEEDED TO THE PT. THE PT WAS REMOVED TO A NEW VENTILATOR WITH A NEW BREATHING CIRCUIT BUT THE FILTER WAS RETAINED. THE PROBLEM PERSISTED; NO EXHALED TIDAL VOLUME WAS DISPLAYED. AFTER EXCHANGE OF THE FILTER THE EXHALED TIDAL VOLUMES WAS NORMAL. THERE WAS NO PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580021 SERVO GUARD CAH MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1