BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 11768164 · Received May 4, 2021

    Report

    Report Number
    1218950-2021-10492
    Event Type
    Death
    Date Received
    May 4, 2021
    Date of Event
    April 28, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER FILED A REPORT STATING "UPON ENTERING THE PATIENT'S ROOM AT 14:57 P.M., THE PATIENT'S MONITOR WAS IN "PAUSE" MODE (WHEN THE PATIENT LAST ENTERED THE ROOM AT THE ROOM AT 13:50, THE MONITOR WAS STILL ACTIVE) AND THE PATIENT SHOWED NO SIGNS OF LIFE. THE PATIENT DIED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER FILED A REPORT STATING "UPON ENTERING THE PATIENT'S ROOM AT 14:57 P.M., THE PATIENT'S MONITOR WAS IN "PAUSE" MODE (WHEN THE PATIENT LAST ENTERED THE ROOM AT THE ROOM AT 13:50, THE MONITOR WAS STILL ACTIVE) AND THE PATIENT SHOWED NO SIGNS OF LIFE. THERE WAS AN IMMEDIATE START OF RESUSCITATION. DURING RESUSCITATION, THE MONITOR SWITCHED TO PAUSE MODE AGAIN AT 15:16HRS. PATIENT DEATH OCCURRED AT 15:41 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664425 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Death