BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7498393 · Received May 9, 2018

    Report

    Report Number
    8010042-2018-00223
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    May 3, 2018
    Report Date
    October 8, 2018
    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

    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

    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 PERON: (B)(6). THE INVESTIGATION OF THE REPORTED COMPLAINT HAS BEEN FINALIZED. THE DEVICE CONTROL PC BOARD WAS REPLACED AND RETURNED FOR INVESTIGATION. THE REPORTED TECHNICAL ERROR CODE WAS REPRODUCED WHEN THE CONTROL PC BOARD WAS INSTALLED IN A TEST VENTILATOR DEVICE. DURING START UP IT WAS NOTED THAT THE RETURNED PC BOARD WAS CONSTANTLY RESTARTING, AND IT WAS NOT POSSIBLE TO SET THE DEVICE IN VENTILATION MODE THE CONCLUSION IN THIS MATTER IS THAT THE REPORTED ISSUE IS CAUSED BY A HARDWARE FAILURE ON THE CONTROL PC BOARD, BUT THE FAULTY COMPONENT HAS NOT BEEN IDENTIFIED, DESPITE ELECTRICAL TROUBLESHOOTING AND MEASUREMENTS PREFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GAVE A TECHNICAL ALARM INDICATING " VENTILATION DISABLED". 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
    342808 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1