BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8774915 · Received July 10, 2019

    Report

    Report Number
    8010042-2019-00471
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 25, 2019
    Report Date
    January 22, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE AIR GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. SIMULATED USE TEST OF THE RECEIVED AIR GAS MODULE HAS REPRODUCED THE DESCRIBED CUSTOMER ISSUE. THE FAILURES WERE CAUSED BY A DEFECTIVE DELTA PRESSURE TRANSDUCER ON A PRINTED CIRCUIT BOARD INSIDE THE GAS MODULE. THE DELTA PRESSURE TRANSDUCER IS PART OF THE FLOW MEASURING IN THE GAS MODULE. THE FAILURE OF THE DELTA PRESSURE TRANSDUCER LEADS TO INACCURATE GAS FLOW REGULATION WHICH WILL BE DETECTED DURING PRE-USE CHECK AND ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. OCULAR INSPECTION SHOWED OIL TRACES IN THE FILTER HOUSING OF THE AIR GAS MODULE WHICH IS THE ROOT CAUSE OF THE DELTA PRESSURE TRANSDUCER'S FAILURE. THE MOST PROBABLE SOURCE OF OIL INTO AN AIR GAS MODULE IS OILY AIR FROM THE HOSPITAL'S EXTERNAL COMPRESSOR. ACCORDING TO THE USER´S MANUAL MAXIMUM LEVELS OF OIL, (OIL < 0,5 MG/M3) IN THE SUPPLIED GASES TO THE VENTILATOR MUST NOT BE EXCEEDED.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 222423.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW SENSOR TEST DURING PRE- USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF.#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568231 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1