BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SC7000/INFINITY DELTA

    MDR report key: 7003832 · Received November 6, 2017

    Report

    Report Number
    1220063-2017-00058
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    September 27, 2017
    Report Date
    January 11, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS STARTED BUT HAS NOT BEEN CONCLUDED. THE OUTCOME WILL BE PUBLISHED IN THE FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FROM RETURN OF THE OPERATING ROOM, ARTERIAL PRESSURE VALUES THAT WERE BEING MEASURED VIA IBP DROPPED FROM 120 TO 180 MMHG, THEN TO 75 MMHG. A FEW MINUTES LATER, VALUES GREW AGAIN TO 120 MMHG. THE PATIENT WAS TREATED FOR HYPERTENSION AND HYPOTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FROM RETURN OF THE OPERATING ROOM, ARTERIAL PRESSURE VALUES THAT WERE BEING MEASURED VIA IBP DROPPED FROM 120 TO 180 MMHG, THEN TO 75 MMHG. A FEW MINUTES LATER, VALUES GREW AGAIN TO 120 MMHG. THE PATIENT WAS TREATED FOR HYPERTENSION AND HYPOTENSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUCTUATING ARTERIAL PRESSURE READINGS. THE DEVICE AND INVOLVED ACCESSORIES WERE TESTED ON SITE BY A DRAEGER SERVICE TECHNICIAN AND THE REPORTED SYMPTOM COULD NOT BE DUPLICATED, NO MALFUNCTION WAS IDENTIFIED. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781825 SC7000/INFINITY DELTA PHYSIOLOGICAL MONITORING SYSTEM CBK DRAEGER MEDICAL SYSTEMS, INC 5203018E539U

    Patients

    Seq Age Sex Outcome Treatment
    1