BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8980418 · Received September 10, 2019

    Report

    Report Number
    8010042-2019-00672
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Report Date
    May 19, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FSE (FIELD SERVICE ENGINEER) INVESTIGATED THE VENTILATOR ON SITE. FSE FOUND OUT THAT EXPIRATORY VALVE COIL WAS NOT GETTING ACTIVATED. THE INVESTIGATION OF THE WIRING OF THE COIL SHOWED THAT THE VALVE WIRE WAS PINCHED AND EXPOSED. THE INTERMITTENT CONNECTION CAUSED THE VALVE COIL TO NOT WORK. EXPIRATORY VALVE COIL WAS REPLACED AND THE VENTILATOR PASSED MULTIPLE PRE USE CHECKS, RETURNED TO CLINICAL USE. THE RECEIVED LOGS CONFIRM THE FAILED FLOW TRANSDUCER TEST AS WELL AS INTERNAL LEAKAGE AND PRESSURE TRANSDUCER TESTS. THE ROOT CAUSE OF THE REPORTED EVENT IS THE PINCHED CABLE OF THE EXPIRATORY VALVE.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 243107.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW TRANSDUCER 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
    775221 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1