BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7735183 · Received July 31, 2018

    Report

    Report Number
    8010042-2018-00388
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 14, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INVESTIGATION OF THE COMPLAINT IS FINALIZED. THE FIELD SERVICE ENGINEER WAS ON SITE FOR INVESTIGATION AND FOUND A SMALL TEAR IN THE EXPIRATORY CHANNEL CONNECTOR AND REPLACED IT. THE EXPIRATORY CHANNEL CONNECTOR BOARD INCLUDING SIGNAL FILTERS THAT IS MOUNTED IN THE EXPIRATORY CASSETTE COMPARTMENT. THE EXCHANGED PART WAS NOT SENT TO US FOR FURTHER INVESTIGATION. WE DO NOT KNOW THE EXTENT OF THE TEAR OR/AND WHICH PART OF THE BOARD THAT WAS AFFECTED. THE VENTILATOR PASSED PRE-USE CHECK BEFORE AND AFTER THE EVENT ACCORDING TO THE RECEIVED LOGS. THE REPORTED ISSUE IS VERIFIED IN THE RECEIVED LOGS. CLINICAL ALARMS SUCH AS VT (TIDAL VOLUME) INSP. OVER RANGE, PEEP (POSTIVE END- EXPIRATORY PRESSURE) LOW AND EXPIRATORY MINUTE VOLUME LOW WERE GENERATED. THESE ALARMS ARE NORMALLY CAUSED BY LEAKAGE. IN THIS CASE, IT IS MOST LIKELY THAT THE CLINICAL ALARMS WERE CAUSED BY THE DAMAGED AND REPLACED PRINTED CIRCUIT BOARD. 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

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR EXPIRATORY MINUTE VOLUME LOW DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577935 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1