BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY DELTA

    MDR report key: 7084726 · Received December 5, 2017

    Report

    Report Number
    1220063-2017-00063
    Event Type
    Death
    Date Received
    December 5, 2017
    Date of Event
    November 29, 2017
    Report Date
    January 23, 2018
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K152407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DELTA MONITOR FAILED TO PROVIDE AN ASYSTOLE ALARM WHILE THE ECG LEAD DISPLAYED SHOWED ASYSTOLE. A SCREENSHOT WAS PROVIDED WHICH VERIFIED THE REPORTED ISSUE. THE DEVICE WAS EVALUATED ON SITE BY A DRAEGER TECHNICIAN AND NO MALFUNCTION WAS IDENTIFIED. ECG STRIPS AND FULL DISCLOSURE INFORMATION WAS NOT AVAILABLE THEREFORE NO ROOT CAUSE CAN BE DETERMINED. ADDITIONAL INFORMATION WAS PROVIDED STATING THERE WAS A DO NOT RESUSCITATE (DNR) ON FILE AND THE CUSTOMER DID NOT ALLEGE THE DELTA MONITOR FAILURE TO ALARM PLAYED A PART IN THE PATIENT DEATH. THEREFORE WE CAN EXCLUDE OUR DEVICE FROM THE PATIENT DEATH. THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE. THIS IS AN ISOLATED CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT'S RELATIVES VISITED THE PATIENT TO SAY GOODBYE TO HIM, THE PATIENT THEN DIED AND THE STATION STAFF NOTICED AFTER SOME TIME THAT THE MONITOR SHOWED A ZERO LINE BUT HAD NOT TRIGGERED AN ASYSTOLE ALARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT'S RELATIVES VISITED THE PATIENT TO SAY GOODBYE TO HIM, THE PATIENT THEN DIED AND THE STATION STAFF NOTICED AFTER SOME TIME THAT THE MONITOR SHOWED A ZERO LINE BUT HAD NOT TRIGGERED AN ASYSTOLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864721 INFINITY DELTA PHYSIOLOGICAL MONITORING SYSTEM CBK DRAEGER MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death