BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3770420 · Received February 18, 2014

    Report

    Report Number
    8010042-2014-00030
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 26, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART WAS REPLACED, OUR INVESTIGATION CONSISTS THEREFORE ONLY OF DEVICE LOG EVAL. RECEIVED EVENT LOGS DON'T COVER THE REPORTED DATE OF EVENT, IT IS THEREFORE NOT POSSIBLE TO CONFIRM REPORTED ALARM. IT IS ALSO NOT POSSIBLE TO VERIFY WHEN THE VENTILATION WAS STARTED OR THE SELECTED VENTILATION MODE AND SETTINGS. TEST LOGS SHOW THAT NO PRE-USE CHECK WAS PERFORMED ON REPORTED DATE OF EVENT. THE LATEST PRE-USE CHECK WAS PERFORMED ON (B)(4) AND PASSED WITHOUT DEVIATION. TECHNICAL LOGS DON'T SHOW ANY ALARMS INDICATING AN EXPIRATORY CASSETTE MALFUNCTION. THE REPORTED ABSENCE OF ALARMS INDICATING A PROBLEM WITH THE EXPIRATORY CASSETTE IS NOT A DEVIATION. BY DESIGN TECHNICAL ALARMS RELATED TO THE EXPIRATORY CASSETTE ARE GENERATED IF: THE EXPIRATORY CASSETTE IS NOT PROPERLY CONNECTED TO PRINTED CIRCUIT BOARD PC1785, EXPIRATORY CHANNEL CONNECTOR. A NEW EXPIRATORY CASSETTE IS CONNECTED AND NO PRE-USE CHECK HAS BEEN PERFORMED. IF VENTILATION IS STARTED AND THE EXPIRATORY CASSETTE IS LOOSE IN A WAY THAT THE CONNECTION WITH PC1785 IS NOT AFFECTED, ALARMS RELATED TO VENTILATION WILL BE GENERATED WHICH WILL NOTIFY THE USER. ACCORDING TO RECEIVED INFO THE REPORTED VENTILATOR IS BACK IN SERVICE WITH NO MORE ISSUES REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT ALARMS FOR HIGH PRESSURE AND HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE) WERE GENERATED. THE STAFF THERAPIST FOUND THAT THIS WAS CAUSED BY A LOOSE EXPIRATORY CASSETTE. THE CUSTOMER'S CONCERN WAS THE ABSENCE OF ANY ALARM INDICATING A PROBLEM WITH THE EXPIRATORY CASSETTE. THERE WAS NO HARM TO PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103159 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI