BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7677502 · Received July 11, 2018

    Report

    Report Number
    8010042-2018-00350
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 21, 2018
    Report Date
    October 11, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE INVESTIGATION OF THE REPORTED PC (PRINTED CIRCUIT) BOARD FAILURE HAS BEEN FINALIZED. IT WAS REPORTED THAT ONE NEW ORDERED CONTROL PC BOARD WAS FAULTY WHEN TRYING TO INSTALL. THE PC BOARD WAS RETURNED FOR INVESTIGATION. THE REVIEW OF THE RETURNED DEVICE LOG REVEALS AN ALARM INDICATING A COMMUNICATION ERROR. THE RETURNED PC BOARD WAS MOUNTED INTO A TEST DEVICE FOR SOFTWARE INSTALLATION. THE INSTALLATION OF SOFTWARE GOT STUCK ON THE FIRST ATTEMPT BUT THE SECOND ATTEMPT WAS SUCCESSFUL. THE DEVICE PASSES THE SYSTEM PRE-USE CHECK WITHOUT ANY DEVIATION, NO PERMANENT FAULT COULD BE ESTABLISH. 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 DURING REPLACEMENT OF THE CONTROL PC BOARD, THE NEW PC BOARD WAS FOUND DEFECTIVE. 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
    522108 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1