BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3150 UPGRADE REL N.01

    MDR report key: 5893284 · Received August 22, 2016

    Report

    Report Number
    1218950-2016-05134
    Event Type
    Death
    Date Received
    August 22, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 18, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PER COMMUNICATIONS WITH THE RCE, THE FSE VISITED THE CUSTOMER SITE TO COLLECT LOGS AND EVALUATE THE DEVICE. THE FSE CONFIRMED THAT POP-UP WINDOWS FOR THE BED-TO-BED OVERVIEW WERE WORKING AND THEIR CONFIGURATIONS WERE FINE, HOWEVER, THE OVERVIEW PROMPT TONE BUTTON WAS NOT CHECKED/ACTIVATED FOR THE POP-UP WINDOW TONE. PER THE RCE, THIS WAS CONFIGURED (NOT CHECKED) BECAUSE THE CUSTOMER DID NOT WANT IT ACTIVATED. THIS IS CONSIDERED A USER CONFIGURATION PREFERENCE. NO DEVICE MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    PATIENT INFO HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ASYSTOLE ALARM FOR A PATIENT DID NOT ALARM VIA OVERVIEW AT THE CENTRAL STATION. THE PATIENT HAD A CARDIAC ARREST AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544902 M3150 UPGRADE REL N.01 CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS M3150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death