BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7582197 · Received June 8, 2018

    Report

    Report Number
    8010042-2018-00290
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 30, 2018
    Report Date
    August 16, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE RETURNED CONTROL PC BOARD DID NOT REPRODUCE THE REPORTED PROBLEM. THE CONTROL PC BOARD WAS TESTED IN A REFERENCE VENTILATOR. PRE-USE CHECK SUCCEEDED AND TEST VENTILATION WAS PERFORMED WITHOUT ANY DEFICIENCY NOTED. THE EVALUATION OF RECEIVED DEVICE LOGS CONFIRMS A SINGLE OCCURRENCE OF THE REPORTED TECHNICAL ERROR CODES AND A STOP OF VENTILATION. THE TECHNICAL ERROR CODES INDICATE DISABLED VALVES AND A CONTROL PC BOARD COMMUNICATION FAILURE WITH THE MONITOR PC BOARD. IF THE UNDERLYING DEFECT APPEARS DURING VENTILATION, VENTILATION WILL STOP AND THE USER WILL BE NOTIFIED TO BY A GENERATED HIGH PRIORITY ALARM AND THE CORRESPONDING TECHNICAL ERROR CODES. IF THE FAILURE APPEARS DURING STARTUP A TECHNICAL ALARM WILL BE GENERATED AND VENTILATION CANNOT BE STARTED. 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 ESTABLISHED. 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 DURING THE USAGE OF DEVICE, THE VENTILATION STOPPED AND THE DEVICE GAVE ALARMS FOR DISABLED VALVES AND OPEN SAFETY VALVE. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426247 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1