BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7436684 · Received April 17, 2018

    Report

    Report Number
    8010042-2018-00190
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    May 25, 2017
    Report Date
    June 27, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS INVESTIGATED ON SITE AND AN EXPIRATORY CHANNEL PRINTED CIRCUIT (PC) BOARD WAS REPLACED AND RETURNED FOR INVESTIGATION. THE REPORTED POWER FAILURE WAS REPRODUCED DURING TEST OF THE RETURNED EXPIRATORY CHANNEL PC BOARD IN A REFERENCE VENTILATOR. DURING PRE-USE CHECK THE INTERNAL LEAKAGE TEST FAILED DUE TO THE SAFETY VALVE IS OPEN, WHEN IT WAS EXPECTED TO BE CLOSED. THE CONCLUSION OF THE INVESTIGATION IS THAT THE ISSUE OCCURRED, DUE TO A SHORT CIRCUIT IN A CAPACITOR THAT IS PART OF THE ELECTRONICS FOR SAFETY VALVE FUNCTION. THE RECEIVED DEVICE LOG CONFIRMS THE REPORTED PROBLEM AND WE COULD TRACE BACK THE REPORTED PROBLEM TO (B)(6) 2017. (B)(4). REF. EXEMPTION #: E2018003. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281086 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1