BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7638323 · Received June 26, 2018

    Report

    Report Number
    8010042-2018-00313
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    June 15, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 OF THE REPORTED COMPLAINT HAS BEEN FINALIZED. THE DEVICE CONTROL PC BOARD WAS REPLACED AND SENT IN FOR INVESTIGATION. THE REPORTED ISSUE WAS REPRODUCED WHEN THE RETURNED CONTROL PC WAS MOUNTED IN A TEST VENTILATOR, THE ALARM INDICATING A COMMUNICATION ERROR WAS GENERATED DURING START-UP. THE CAUSE WAS DUE TO A FAULTY CRYSTAL ON THE CONTROL PC BOARD. WHEN THE CRYSTAL WAS REPLACED, THE BOARD REGAINED ITS FUNCTION ACCORDING SPECIFICATION AND PASSED THE PRE-USE CHECK TESTS. THE ROOT CAUSE TO WHY THE CRYSTAL HAS FAILED HAS NOT BEEN DETERMINED BY THIS INVESTIGATION. 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)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR INDICATING A COMMUNICATION 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
    479198 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1