BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7548564 · Received May 29, 2018

    Report

    Report Number
    8010042-2018-00261
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 10, 2018
    Report Date
    July 31, 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
    OTHER

    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

    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

    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). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. THE REPORTED FAILURES IN PRE-USE CHECK WERE REPRODUCED DURING TEST OF THE RETURNED O2 GAS MODULE IN A REFERENCE VENTILATOR. THE FAILURES WERE CAUSED BY A DEFECTIVE DELTA PRESSURE TRANSDUCER ON A PRINTED CIRCUIT BOARD INSIDE THE O2 GAS MODULE. THE DELTA PRESSURE TRANSDUCER IS PART OF THE FLOW MEASURING IN THE GAS MODULE. THE FAILURE OF THE DELTA PRESSURE TRANSDUCER LEADS TO INACCURATE GAS FLOW REGULATION WHICH WILL BE DETECTED DURING PRE-USE CHECK AND ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. THE FAILURE WAS CONFIRMED IN RECEIVED DEVICE LOGS. WE COULD TRACE BACK THE REPORTED PROBLEM TO MAY 10, THEREFORE THE DATE OF EVENT WAS DETERMINED AS (B)(6)2018. WHY THE DELTA PRESSURE TRANSDUCER FAILED, COULD NOT BE DETERMINED IN THIS INVESTIGATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    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
    393564 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1