BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP5

    MDR report key: 8226008 · Received January 8, 2019

    Report

    Report Number
    9610816-2019-00008
    Event Type
    Death
    Date Received
    January 8, 2019
    Date of Event
    January 2, 2019
    Report Date
    January 2, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    BZQ
    PMA / PMN Number
    K091395
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED, NOT AVAILABLE AT TIME OF REPORT. DATE OF EVENT HAS BEEN REQUESTED, NOT AVAILABLE AT TIME OF REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF THE DEVICE OCCURRED. THE DEVICE WORKED AS INTENDED. THE ISSUE WAS CAUSED BY A MISUSE OF THE ALARMS BY THE STAFF. THE CUSTOMER WAS INFORMED ABOUT THE OUTCOME OF THE ANALYSIS BY THE INVOLVED REMOTE SUPPORT TECHNICIAN. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PROBLEM OCCURRED THIS MORNING AT 06:00, ALARMS DID NOT SOUND. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18338 MP5 PATIENT MONITOR BZQ PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death