BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7720574 · Received July 25, 2018

    Report

    Report Number
    8010042-2018-00378
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    July 17, 2018
    Report Date
    February 6, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PERON: (B)(4).

    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 PERON: (B)(4). THE INVESTIGATION OF THE REPORTED COMPLAINT HAS BEEN FINALIZED. THE DEVICE CONTROL PC (PRINTED CIRCUIT)BOARD WAS REPLACED AND RETURNED FOR INVESTIGATION. THE REPORTED TECHNICAL ERROR CODE WAS REPRODUCED DURING TESTING WITH THE RETURNED CONTROL PC BOARD. WHEN THE DEVICE WAS POWERED ON, IT WAS NOTED THAT THE PC BOARD WAS CONSTANTLY RE-STARTING, THIS INDICATES A SIGNAL ERROR CAUSED BY A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR COMMUNICATION ERROR AND INTERNAL MEMORY ERROR. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559416 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1