BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7403434 · Received April 6, 2018

    Report

    Report Number
    8010042-2018-00177
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 19, 2018
    Report Date
    April 6, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIELD SERVICE ENGINEER NOTED A WHITE RESIDUE OF DRIED LIQUID ON THE CONNECTOR ON THE MONITORING PC BOARD. THE PC BOARD WAS REPLACED AS A CORRECTIVE ACTION. THE SYSTEM SOFTWARE WAS REINSTALLED AND THE VENTILATOR THEN PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS CLEARED FOR CLINICAL USE. THERE IS NO INFORMATION ON HOW THE LIQUID SPILL ENTERED THE VENTILATOR OR WHAT KIND OF LIQUID SPILL IT WAS. INGRESS OF LIQUID SUBSTANCE ON PC BOARDS CAN CAUSE FAILURE/SHORT CIRCUITS WHICH MIGHT LEAD TO VARIOUS ALARMS AND FAILURE. THE VENTILATOR SYSTEM WAS MANUFACTURED IN YEAR 2011, TO THE APPLICABLE STANDARDS AT THE TIME FOR LIQUID SPILL INGRESS PROTECTION. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING MAINTENANCE IT WAS NOTICED TRACES OF LIQUID AND CORROSION ON THE MONITORING PC BOARD. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248227 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1