BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 9937969 · Received April 8, 2020

    Report

    Report Number
    8010042-2020-00203
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 16, 2020
    Report Date
    May 10, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIELD SERVICE TECHNICIAN INVESTIGATED THE VENTILATOR ON SITE. A PRE-USE CHECK WAS PERFORMED AND PASSED. VENTILATION ON TEST-LUNG PERFORMED WITHOUT ISSUES. THE PROBLEM COULD NOT BE REPRODUCED AND THE VENTILATOR WAS RETURNED IN WORKING CONDITION. THE DATE OF EVENT WAS NOT GIVEN. EVALUATION OF THE DEVICE LOGS SHOW THAT THE LAST COMPLETE PRE-USE CHECK BEFORE THE REPORTED EVENT WAS PERFORMED ON 2020-01-18. AFTER THIS THE PATIENT CIRCUIT LEAKAGE TEST HAVE BEEN PERFORMED A COUPLE OF TIMES, THE LAST WAS PERFORMED ON 2020-03-12. THE EVENT LOG STARTS IN ONGOING VENTILATION ON 2020-03-14 AND CONTINUES UNTIL 2020-03-15 AT 17:08 WHEN THE VENTILATOR WAS SET TO STANDBY. VENTILATION MODE, PARAMETER SETTINGS AND PATIENT CATEGORY IS UNKNOWN. EVALUATION OF THE EVENT LOG CONFIRM THE ALARM "EXPIRATORY MINUTE VOLUME LOW". THE ALARM HAVE BEEN GENERATED SEVERAL TIMES DURING THE TWO DAYS THAT IS COVERED IN THE LOG. THE ONLY PARAMETER THAT WAS CHANGED DURING THE VENTILATION WAS THE OXYGEN CONCENTRATION. EVALUATION OF THE DEVICE LOGS CAN CONFIRM THE REPORTED EXPIRATORY MINUTE VOLUME LOW ALARMS BUT SINCE THE ISSUE COULD NOT BE REPRODUCED, THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REF # (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403010 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1