BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-S

    MDR report key: 10527852 · Received September 14, 2020

    Report

    Report Number
    3013876692-2020-00047
    Event Type
    Death
    Date Received
    September 14, 2020
    Date of Event
    August 14, 2020
    Report Date
    March 23, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER. THE VENTILATOR PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS CLEARED FOR CLINICAL USE. AN EVENT LOG IN TXT-FORMAT WAS PROVIDED. THE PATIENT REPORTEDLY EXPIRED ON AUGUST 14, 2020 AT 2:35 PM. THE LOGS DOES NOT CONTAINS ANY SHUTDOWNS OR TECHNICAL ERROR CODES AT THAT TIME. THERE ARE NO INDICATIONS OF A VENTILATOR MALFUNCTION. FROM THE USER, THERE ARE NO ALLEGATIONS OF A VENTILATOR MALFUNCTION OR THAT THE VENTILATOR CONTRIBUTED TO THE PATIENT¿S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED WHILE ON VENTILATOR. THE USER FACILITY DOES NOT BELIEVE THAT THERE WAS ANY VENTILATOR MALFUNCTION, BUT REQUESTS AN EXAMINATION. (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995151 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1 69 DA Death