BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMUS IE

    MDR report key: 8263539 · Received January 21, 2019

    Report

    Report Number
    9611500-2019-00022
    Event Type
    Death
    Date Received
    January 21, 2019
    Date of Event
    December 12, 2018
    Report Date
    March 8, 2019
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION AND ANALYSIS OF THE LOGFILE, THE CASE IN QUESTION COULD BE RECONSTRUCTED AND NO INDICATIONS FOR A MALFUNCTION OF THE DEVICE OR ONE OF ITS COMPONENTS WERE FOUND. THE LOGFILE SHOWS THAT THE CASE WAS STARTED AT 8:52AM USING THE EXT. OUTLET/AUX CGO. AT 8:53AM, THE UNIT WAS PLACED IN STANDBY BEFORE THE PROCEDURE WAS CONTINUED IN EXT. OUTLET AT 8:56AM. ACCORDING TO THE FOLLOWING RECORDS, A PRESSURE BUILD-UP WAS POSSIBLE AS AIRWAY PRESSURES UP TO 33 MBAR WERE MEASURED AND OCCASIONALLY PRESSURE HIGH ALARMS WERE GIVEN. THE INSPIRATORY O2 LEVEL WAS ABOVE 90% AND ETCO2 AROUND 20 MMHG. AT APPROX. 9:08AM, THE PATIENT OBVIOUSLY WAS DISCONNECTED AS NO FURTHER ETCO2 WAS DETECTED. AT 10:11AM, THE UNIT WAS PLACED IN STANDBY AND AFTERWARDS, A LEAK TEST WAS SUCCESSFULLY COMPLETED. THE LOGFILE ANALYSIS REVEALED NO INDICATIONS FOR A DEVICE MALFUNCTION, NEITHER DURING NOR BEFORE OR AFTER THE REPORTED EVENT. VENTILATOR AND GAS DOSAGE WERE FULLY FUNCTIONAL DURING THE WHOLE CASE. DRÄGER FINALLY CONCLUDES THAT THE PATIENT DEATH WAS NOT THE RESULT OF A DEVICE MALFUNCTION. THE DEVICE OPERATED ACCORDING TO ITS SPECIFICATION.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL-REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED. PER ACTUAL STATE OF KNOWLEDGE, THERE IS NO FURTHER INFORMATION AVAILABLE ABOUT THE CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58389 PRIMUS IE ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death