BEUDAMED
    FDA Adverse Event Death Summary report: N

    259CX CTG MONITOR

    MDR report key: 8537514 · Received April 22, 2019

    Report

    Report Number
    9617277-2019-00001
    Event Type
    Death
    Date Received
    April 22, 2019
    Report Date
    August 2, 2019
    Manufacturer
    WIPRO GE HEALTHCARE PRIVATE LTD.
    Product Code
    HGM
    PMA / PMN Number
    K072976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE WAS MADE AWARE OF AN EVENT INVOLVING A STILL-BIRTH THAT OCCURRED SOMETIME IN 2018. NO ALLEGATION WAS MADE AGAINST GE HEALTHCARE EQUIPMENT. GE HEALTHCARE HAS NOT BEEN PROVIDED ANY INFORMATION REGARDING THE CLINICAL SCENARIO THAT LED TO THE EVENT OR REGARDING THE PATIENT HISTORY. AS PART OF THE HOSPITAL'S INTERNAL INVESTIGATION, GE HEALTHCARE WAS ASKED ABOUT THE NORMAL OPERATION OF THE ALARMS OF THE COROMETRICS MONITORS AND ADDITIONAL INFORMATION REGARDING THE IMPLEMENTATION OF ALARM. GE HEALTHCARE WAS ABLE TO RESPOND TO THE HOSPITAL'S REQUEST BY PROVIDING INFORMATION AVAILABLE FROM THE MANUAL. GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. FROM THE EVENT INFORMATION PROVIDED BY THE HOSPITAL , THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT THAT OCCURRED AND THE UNIT IS WORKING AS INTENDED. THE CUSTOMER HAS CONFIRMED THAT THERE IS NO ISSUE WITH THE EQUIPMENT. THE ROOT CAUSE HAS BEEN IDENTIFIED AS A USER ERROR?.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE¿¿S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED AN ALLEGED FAILURE OF THE FETAL MONITOR TO RE-ALARM FOR A LOW FETAL HEART RATE. THE FETUS WAS STILLBORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328645 259CX CTG MONITOR SYSTEM, MONITORING, PERINATAL HGM WIPRO GE HEALTHCARE PRIVATE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death