BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8943772 · Received August 29, 2019

    Report

    Report Number
    8010042-2019-00630
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 9, 2019
    Report Date
    March 20, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). IT WAS NOTED THAT THE O-RING ON THE NOZZLE UNIT IN THE AIR GAS MODULE HAD BECOME DISLODGED FROM ITS SEATING. THE O-RING WAS RESEATED AND THE VENTILATOR THEN PASSED PRE-USE CHECK AND DELIVERED SET O2 CONCENTRATION CORRECTLY DURING 3 DAYS OF OBSERVATION. VENTILATOR LOGS CONFIRM THE REPORTED EVENT OF GENERATED ALARMS FOR LOW O2 CONCENTRATION. THE LOGS DO NOT CONTAIN ANY TECHNICAL ERROR CODES INDICATING ANY VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. THE VENTILATOR PASSED PRE-USE CHECK PRIOR AND AFTER THE EVENT DATE. THE ROOT CAUSE OF THE REPORTED ALARMS IS MOST LIKELY THE DISLODGED O-RING ON THE NOZZLE UNIT. HOW THE O-RING HAS BECOME DISLODGED HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 240582.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR LOW O2 CONCENTRATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737231 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1