BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 8217260 · Received January 4, 2019

    Report

    Report Number
    8010042-2019-00008
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 12, 2018
    Report Date
    April 12, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    NO VENTILATOR LOGS HAVE BEEN PROVIDED BY THE USER FACILITY AND NO SERVICE WAS REQUESTED. THE USER FACILITY DECIDED TO CONTINUE TO USE THE VENTILATOR AS IT OTHERWISE WAS WORKING WELL. FURTHER INFORMATION WAS REQUESTED BUT NO RESPONSE HAS BEEN RECEIVED. DUE TO THE LIMITED INFORMATION PROVIDED, NO INVESTIGATION HAS BEEN POSSIBLE. THEREFORE THE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED. 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)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS MANUALLY DISCONNECTED FROM THE VENTILATOR FOR ROUTINE SUCTIONING. AFTER RECONNECTING THE PATIENT TO THE VENTILATOR, IT DID NOT RESTART. THERE WAS NO PATIENT HARM. 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
    9699 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1