BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3150 INFORMATION CENTER LOCAL DATABASE

    MDR report key: 3853641 · Received May 23, 2014

    Report

    Report Number
    1218950-2014-02898
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO CHECK THE CONFIGURATIONS AND TEST THE DEVICE WHICH FOUND NO ISSUES. BED TO BED OVERVIEW ALARMS CANNOT BE VERIFIED VIA LOGS, THUS IT CANNOT BE CONFIRMED IF THE DEVICE ALARMED APPROPRIATELY AT THE TIME OF THE INCIDENT. PER COMMUNICATIONS WITH THE FSE, THE CUSTOMER DOES NOT ALLEGE THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH SINCE THEY WERE ANTICIPATING THE PASSING OF THE PATIENT. THE FUNCTIONALITY OF THE DEVICE CANNOT BE CONFIRMED DURING THE REPORTED INCIDENT, HOWEVER, THE CONFIGURATIONS WERE CONFIRMED AS CORRECT BY THE FSE AND TESTING PERFORMED BY THE FSE FOUND NO ISSUES WITH THE BED TO BED ALARMING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A BED TO BED OVERVIEW RED ALARM DID NOT RELAY FOR ROOM 212 BETWEEN 1300-1310 AND A PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309112 M3150 INFORMATION CENTER LOCAL DATABASE MHX PHILIPS MEDICAL SYSTEMS M3150 DC7700

    Patients

    Seq Age Sex Outcome Treatment
    1 Death