BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 16875892 · Received May 5, 2023

    Report

    Report Number
    8010042-2023-00872
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 21, 2023
    Report Date
    May 5, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER ON-SITE AND THE EXPIRATORY MEMBRANE WAS DETERMINED DEFECTIVE AND REPLACED WHICH SOLVED THE ISSUE. NO LOG FILES WERE PROVIDED AND NO REPLACED PARTS HAVE BEEN RETURNED FOR TECHNICAL INVESTIGATION. THE ROOT CAUSE TO THE REPORTED FAILURE HAS NOT BEEN ESTABLISHED IN THIS INVESTIGATION.

    Description of Event or Problem · 0

    MANUFACTURER REF#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 810190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575206 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown