BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8959157 · Received September 4, 2019

    Report

    Report Number
    8010042-2019-00660
    Event Type
    Malfunction
    Date Received
    September 4, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FSE (FIELD SERVICE ENGINEER) WAS ON SITE AND INVESTIGATED THE REPORTED ISSUE. WATER WAS FOUND IN THE INLET OF BREATHING CIRCUIT THAT CONNECTS TO THE VENTILATOR. THE WATER WAS DRAINED AND THE VENTILATOR PASSED ALL THE FUNCTIONAL AND SAFETY TESTS AND RETURNED TO CLINICAL USE. IN THE RECEIVED EVENT LOG, IT CAN BE SEEN THAT THE VENTILATOR GENERATED SEVERAL ALARMS THAT MAY INDICATE A LEAKAGE IN THE SYSTEM. THE PRE-USE CHECK WAS CANCELLED SEVERAL TIMES BEFORE AND ON THE EVENT DATE. THE ROOT CAUSE OF THE REPORTED EVENT IS THE CONTAMINATION OF THE WATER IN THE INLET THAT CONNECTS THE BREATHING CIRCUIT AND THE VENTILATOR SYSTEM.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 243436.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIR INLET OF THE VENTILATOR WAS FOUND WITH WATER IN IT. THERE WAS NO PATIENT HARM. MANUFACTURER REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753143 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1