BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4110433 · Received September 16, 2014

    Report

    Report Number
    8010042-2014-00404
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    January 10, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED EXPIRATORY CHANNEL PRINTED CIRCUIT (PC) BOARD HAS BEEN COMPLETED. THIS BOARD CONTAINS ELECTRONICS, WHICH INCLUDE MICROPROCESSOR FOR HANDLING CONTROL OF THE SAFETY VALVE FUNCTIONS IN THE INSPIRATORY SECTION. INVESTIGATION OF THE EXPIRATORY CHANNEL PC BOARD REPRODUCED THE REPORTED PROBLEM. THE PRE-USE CHECK FAILED THE INTERNAL LEAKAGE TEST, PRESSURE TRANSDUCER TEST AND SAFETY VALVE TEST DUE TO THAT THE SAFETY VALVE OPEN AND CLOSE CONTINUOUSLY. THE CONCLUSION OF THE INVESTIGATION IS THAT THE PROBLEM OCCURRED, DUE TO FAULTY CAPACITOR THAT IS PART OF THE ELECTRONICS FOR SAFETY VALVE FUNCTION. THIS EXPLAINS THE REPORTED PRE-USE CHECK FAILURE AND THE PULL MAGNET NOISE. THE ROOT CAUSE OF WHY THE CAPACITOR FAILED HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR MADE A NOISE. THE PROBLEM OCCURRED INTERMITTENTLY IMMEDIATELY AFTER START UP WHEN PRE-USE CHECK WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573829 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1