BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8095893 · Received November 21, 2018

    Report

    Report Number
    8010042-2018-00623
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 28, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE COMPLAINT RELATED TO CORROSION/LIQUID SPILL ON THE REPORTED VENTILATOR¿S PRINTED CIRCUIT (PC) BOARDS HAS BEEN COMPLETED. DURING INVESTIGATION ON-SITE PERFORMED BY OUR FIELD SERVICE ENGINEER PRESENCE OF LIQUID SPILL ON THE PC BOARD(S) WAS FOUND. THE PCB¿S WERE REPLACED AND AFTER SUCCESSFUL TESTS THE VENTILATOR WAS SENT BACK IN SERVICE. A VISUAL INSPECTION CONFIRMS THE REPORTED LIQUID SPILL PROBLEM. THE PCB¿S WERE NOT FURTHER INVESTIGATED SINCE INGRESS OF LIQUID ON PCB CAN CAUSE FAILURE/SHORT CIRCUITS WHICH MIGHT LEAD TO A VENTILATOR MALFUNCTION. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    IT WAS NOTICED DURING SERVICE THAT THE ELECTRONIC CIRCUITS WERE DAMAGED WITH LIQUID. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935295 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1