BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8185665 · Received December 20, 2018

    Report

    Report Number
    8010042-2018-00687
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 13, 2018
    Report Date
    March 26, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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).

    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 BY THE HOSPITAL BIOMEDICAL ENGINEER. NO ERRORS WERE REPRODUCED. THE CONTROL PC BOARD WAS REPLACED AS A PRECAUTION ACCORDING TO RECOMMENDATIONS IN THE DEVICE SERVICE MANUAL. THE DEVICE LOGS WERE DOWNLOADED. EVALUATION OF THE RECEIVED DEVICE LOGS CONFIRMS A SINGLE OCCURRENCE OF TWO TECHNICAL ERROR (TE) CODES AND CLINICAL ALARMS INDICATING A STOP OF VENTILATION. THE TE CODES WERE THE REPORTED TE CODE INDICATING DISABLED VALVES AND A TE CODE INDICATING A CONTROL PC BOARD COMMUNICATION FAILURE WITH THE MONITOR PC BOARD. THE TE CODES OCCURRED ON (B)(6)2018. THE EVENT DATE HAS BEEN UPDATED ACCORDINGLY. INVESTIGATION OF THE RETURNED CONTROL PC BOARD MOUNTED IN A TEST VENTILATOR DID NOT REPRODUCE THE REPORTED FAILURE. PRE-USE CHECK SUCCEEDED AND SIMULATE USE TESTING IN VENTILATION MODE WAS PERFORMED DURING 13 DAYS WITHOUT ANY DEFICIENCY NOTED. THE CONCLUSION IN THIS MATTER IS THAT THE REPORTED ISSUE WAS CONFIRMED IN THE RECEIVED DEVICE LOGS BUT COULD NOT BE REPRODUCED DURING THE INVESTIGATION. THE CAUSE OF THE REPORTED FAILURE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE, INDICATING DISABLED VALVES. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #:(B)(4). MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023683 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1