BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8095680 · Received November 21, 2018

    Report

    Report Number
    8010042-2018-00622
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 13, 2018
    Report Date
    February 27, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 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 PERSON: (B)(4). THE INVESTIGATION REGARDING THE REPORTED COMPLAINT HAS BEEN FINALIZED. THE VENTILATOR DEVICE WAS INVESTIGATED AT THE HOSPITAL BY OUR FIELD SERVICE ENGINEER (FSE), NO ERRORS OR FAULT WAS REPRODUCED DURING THE ON-SITE INVESTIGATION. THE DEVICE CONTROL PC BOARD WAS REPLACED ACCORDING TO THE RECOMMENDATION IN THE SERVICE MANUAL AS A PRECAUTION. THE ALARM CAN BE CONFIRMED BY THE REVIEW OF THE DEVICE LOGS, THERE ARE NO OTHER FINDINGS OF ALARMS OR GENERATED ERRORS IN THE LOGS. THE INVESTIGATION OF THE RETURNED CONTROL PC(PRINTED CIRCUIT) BOARD CANNOT VERIFY ANY ERRORS, THE BOARD FUNCTION WAS ACCORDING SPECIFICATION. THE ROOT CAUSE TO THE REPORTED EVENT CANNOT BE CONFIRMED BY THIS INVESTIGATION. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE, INDICATING SOFTWARE ERROR.THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937575 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1