BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3155 RELEASE L.0 UPGRADE

    MDR report key: 3863016 · Received June 4, 2014

    Report

    Report Number
    1218950-2014-02902
    Event Type
    Death
    Date Received
    June 4, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 9, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHILIPS SOLUTION CENTER (SC) PROVIDED PHONE ASSISTANCE. LOGS WERE SENT IN AND REVIEWED. THE CUSTOMER INDICATED THAT THE LEADS OFF ALARMS WERE SET TO YELLOW. PIIC LOGS DO NOT LOG YELLOW ALARMS, THUS THE EVENTS OF THE INCIDENT COULD NOT BE CONFIRMED, HOWEVER, AN ASYSTOLE ALARM DID SOUND AT 1743 WHICH WAS SILENCED BY USERS INDICATING THAT THE DEVICE WAS AUDIBLY ALARMING. PER COMMUNICATIONS WITH THE BIOMEDICAL ENGINEER THE DEVICE WAS TESTED AND FOUND TO BE WORKING AS EXPECTED AND CONFIGURED. THE BIOMEDICAL ENGINEER STATED HE FELT COMFORTABLE THAT THE DEVICE/SYSTEM WAS OPERATING PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT EXPIRED POST-SURGERY AFTER REMOVING THEIR MONITORING LEADS, AND THE CUSTOMER WANTED TO FIND OUT IF THE SYSTEM FAILED TO ALARM "LEADS OFF" OR IF THE ALARMS WERE IGNORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326220 M3155 RELEASE L.0 UPGRADE MHX PHILIPS MEDICAL SYSTEMS M3155 RP5700 TURBO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death