BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7666294 · Received July 6, 2018

    Report

    Report Number
    8010042-2018-00332
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 14, 2018
    Report Date
    October 30, 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
    PHYSICIAN

    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 REGARDING THE REPORTED COMPLAINT HAS BEEN FINALIZED. THE UNIT WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). THE INVESTIGATION CONCLUDED THAT THE PANEL WAS BLACK DURING SYSTEM START-UP. THE PANEL PC(PRINTED CIRCUIT) BOARD AND DC/DC PC BOARD WERE REPLACED. OUR EVALUATION OF THE RETURNED DEVICE LOGS SHOW THAT THERE WAS A COMMUNICATION ERROR BETWEEN THE PANEL AND MONITORING SUBSYSTEM DURING START-UP. THIS EVENT DOES NOT AFFECT ONGOING VENTILATION, IF THE EVENT OCCURS AT START-UP THE SCREEN WILL NOT LIGHT UP AND VENTILATION CANNOT BE STARTED. OUR CONCLUSION INTO THIS MATTER IS THAT THE EVENT IS DUE TO THE FAULTY PC BOARDS. 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 THE VENTILATOR WAS NOT SWITCHING ON. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510254 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1