BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3155 UPGRADE REL N.0

    MDR report key: 6636055 · Received June 13, 2017

    Report

    Report Number
    1218950-2017-03923
    Event Type
    Death
    Date Received
    June 13, 2017
    Date of Event
    May 14, 2017
    Report Date
    May 15, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE), COLLECTED THE LOG FILES. THE LOGS WERE REVIEWED AND SHOWED THAT FROM (B)(6) 2017 13:50 TO (B)(6) 2017 22:02, THERE WERE NUMEROUS DESAT ALARMS OCCURRING SOME OF WHICH WERE SILENCED AND/OR SUSPENDED BY USERS. PER COMMUNICATIONS WITH THE ICU CLINICAL NURSE SPECIALIST, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION AND/OR THAT THE DEVICE CONTRIBUTED TO THE PATIENT EVENT, HOWEVER, THEY WANTED TO BE ABLE TO REVIEW THE ALARM DATA TO UNDERSTAND USER RESPONSE OR NON-RESPONSE TO ALARMS PROVIDED. THE ALARM LOG DATA WAS PROVIDED TO THE CUSTOMER FOR REVIEW. BASED ON THE INFORMATION, USER ALARM HANDLING CANNOT BE RULED OUT AS A FACTOR. NO DEVICE MALFUNCTION OCCURRED IS SUPPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS SEEKING A LIST OF ALARMS FROM THE AUDIT LOG FOR THE PATIENT IN ROOM 512 FROM (B)(6) 2017 13:00 TO (B)(6) 2017 02:00 FOR REVIEW. FURTHER COMMUNICATIONS WITH THE ICU CLINICAL NURSE SPECIALIST INDICATED THAT THE PATIENT FELL AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418883 M3155 UPGRADE REL N.0 CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS M3155

    Patients

    Seq Age Sex Outcome Treatment
    1 Death