BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7560966 · Received June 1, 2018

    Report

    Report Number
    8010042-2018-00273
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    December 21, 2017
    Report Date
    September 20, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED COMPLAINT HAS BEEN FINALIZED. THE REPORTED DEVICE WAS INVESTIGATED AT THE HOSPITAL BY OUR FIELD SERVICE ENGINEER, THE ERROR COULD NOT BE REPRODUCED DURING THE ON-SITE INVESTIGATION. THE DEVICE CONTROL PC (PRINTED CIRCUIT) BOARD WAS EXCHANGED FOR PRECAUTION. THE VISUAL INSPECTION OF THE CONTROL PC BOARD DID NOT REVEAL ANY ERRORS. THE REPORTED TECHNICAL ALARMS WERE NOT REPRODUCED DURING TEST OF THE RETURNED VENTILATOR. HOWEVER IT WAS NOTICED THAT THE FACTORY INSTALLED CONTROL PC BOARD WAS NOT MOUNTED WHEN THE VENTILATOR ARRIVED. WE CAN'T CONFIRM IF THE FACTORY INSTALLED CONTROL PC BOARD WAS MOUNTED AT THE TIME OF EVENT. THE REVIEW OF THE RETURNED DEVICE LOGS COULD CONFIRM THE OCCURRENCE OF THE TECHNICAL ALARM. OUR IN-HOUSE INVESTIGATIONS HAVE SHOWN THAT THE ERROR IS A SOFTWARE FLAW. 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 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    THE VENTILATOR'S LOGS THAT WERE RECEIVED FOR AN INITIALLY REPORTED COMMUNICATION ERROR COMPLAINT ALSO CONTAINED 3 OTHER TECHNICAL ALARMS THAT INDICATE PATIENT CATEGORY MISMATCH, DISABLED VALVES AND SUBSYSTEM MISMATCH OF PATIENT CATEGORY DURING VENTILATION. THERE WAS NO PATIENT HARM. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403457 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1