BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 11867540 · Received May 21, 2021

    Report

    Report Number
    3010157426-2021-00029
    Event Type
    Death
    Date Received
    May 21, 2021
    Date of Event
    May 10, 2021
    Report Date
    September 3, 2021
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER COULD NOT RETRIEVE XTR LOGS, ICS SINGLE PATIENT EXTRACT, AND XHIBIT LOGS THE FILES NEEDED TO INVESTIGATE THE REPORTED ISSUE FROM THE HOSPITAL SITE. BECAUSE THE TRANSMITTER WAS IN ACTIVE USE DURING THE TIME OF THE VISIT. WHILE ONSITE, THE FSE DID OBSERVE ALARMS OPERATING ACCORDING TO SPECIFICATIONS FOR THE PATIENT CONNECTED TO THE DEVICE THAT WAS BEING USED IN THE REPORTED COMPLAINT EPISODE. THIS REPORT IS COMPLETE, AND THIS ISSUE IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2021, OF FAILURE TO ALARM. NO INJURY WAS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761185 SPACELABS XHIBIT CENTRAL STATION XHIBIT CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1