BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 12601813 · Received October 8, 2021

    Report

    Report Number
    3010157426-2021-00058
    Event Type
    Death
    Date Received
    October 8, 2021
    Date of Event
    August 18, 2021
    Report Date
    November 12, 2021
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAILURE WAS FOUND, THE 91496 MODULE RECOGNIZED AN EPISODE OF BRADYCARDIA THAT TRANSITIONED TO ASYSTOLE AND THEN GENERATED A SERIES OF MEDIUM AND HIGH PRIORITY ALARMS. THE FSE WENT ON-SITE AND TESTED ALL PRODUCTS REFERENCED IN THE REPORTED EVENT ACCORDING TO THE PERFORMANCE TEST LISTED IN THE SERVICE MANUAL. ALL TESTS PASSED, INCLUDING BOTH VISIBLE AND AUDIBLE ALARM NOTIFICATIONS. THIS REPORT IS CONSIDERED FINAL.

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON SEPTEMBER 20, 2021. SPACELABS FIELD SERVICE ENGINEER REPORTED THERE WAS A FAILURE TO ALARM IN ICU BED 5154 AT 8:18AM (B)(6) 2021, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499015 SPACELABS XHIBIT CENTRAL STATION XHIBIT CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death