BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8879314 · Received August 9, 2019

    Report

    Report Number
    8010042-2019-00584
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 18, 2019
    Report Date
    March 25, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE O2 CONCENTRATION WAS UNSTABLE DURING PATIENT TREATMENT AND THE VENTILATOR LOGS THAT WERE RECEIVED CONTAIN HIGH PRESSURE ALARMS. NO FURTHER INFORMATION HAS BEEN RECEIVED OF SERVICE MEASURES AND NO PARTS OR INFORMATION OF REPLACED PARTS HAVE BEEN RECEIVED. EVALUATION OF THE RECEIVED DEVICE LOG SHOWS MATCHING EVENTS ON THE REPORTED EVENT DAY. A PRE-USE CHECK WAS CONFIRMED TO BE SUCCESSFUL PRIOR AND AFTER TO THIS VENTILATION PERIOD. IF THIS FAULT HAPPENS DURING VENTILATION AND PROVIDED IT IS NOT A FAILURE IN THE MEASURING PART OF THE VENTILATOR, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATES FROM THE EXPECTED. FLOW AND PRESSURE MAY ALSO DEVIATE FROM THE EXPECTED. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. HIGH AIRWAY PRESSURE ALARMS ARE COMMON DURING PATIENT TREATMENT. THEY CAN BE PATIENT RELATED AND/OR DUE TO PARAMETER AND ALARM LIMITS' SETTINGS. AS NO GOODS WERE RETURNED FOR INVESTIGATION AND NO INFORMATION REGARDING SERVICE MEASURES WAS RECEIVED, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REF. #: 231875.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE O2 CONCENTRATION WAS UNSTABLE DURING PATIENT TREATMENT AND THE VENTILATOR LOGS THAT WERE RECEIVED CONTAIN HIGH PRESSURE ALARMS. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673478 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1