BEUDAMED
    FDA Adverse Event Death Summary report: N

    SV300 VENTILATOR

    MDR report key: 10372575 · Received August 6, 2020

    Report

    Report Number
    3009156722-2020-00009
    Event Type
    Death
    Date Received
    August 6, 2020
    Date of Event
    July 5, 2020
    Report Date
    July 8, 2020
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    ONZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2020 AT 11:20AM. EVALUATION OF SYSTEM LOGS INDICATES A "TUBE DISCONNECTED?" ALARM WAS TRIGGERED AT 10:22 AND LASTED FOR 5 MINUTES. CONCURRENTLY, ALARMS FOR "APNEA" AND "MV TOO LOW" WERE TRIGGERED. ADDITIONAL ALARMS WERE TRIGGERED AND ALARMED CONTINUOUSLY FOR 10 MINUTES BETWEEN 11:17AM AND 11:27AM. DURING THIS PERIOD THE ONLY INTERACTION WITH THE SYSTEM WAS AN ADJUSTMENT TO THE RESPIRATOR RATE. THE ALARMS RESULTED FROM A SEPARATION/LEAK BETWEEN THE SAFETY VALVE ASSEMBLY AND THE SAFETY VALVE ASSEMBLY HAND WHEEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPIRED WHILE BEING VENTILATED ON A SV300 VENTILATOR. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838003 SV300 VENTILATOR SV300 VENTILATOR ONZ SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death