BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 11915947 · Received June 1, 2021

    Report

    Report Number
    1218950-2021-10616
    Event Type
    Death
    Date Received
    June 1, 2021
    Date of Event
    May 4, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT OUTCOME, THE PATIENT DIED, NO OTHER INFORMATION WAS AVAILABLE AT TIME OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MONITOR PRESENTED WITH THE FOLLOWING MALFUNCTION: "THE CENTRAL STATION WOULD CRASH WHEN SELECTING SECTOR FOR P568. AFTER TROUBLESHOOTING THE ISSUE WITH OUR NSS WE FOUND OUT THAT THE STAFF ENTER THE PATIENT NAME AS (B)(6) UKNOWNEV AND WITH A BIRTH YEAR OF (B)(6) WE FOUND OUT THAT OUR PIC IX SYSTEM IS CODED TO ONLY GO BACK AS FAR AS 1900 AND ANYTHING BEFORE THAT YEAR WILL CRASH THE SYSTEM". THE DEVICE WAS IN USED AND IT WAS REPORTED THAT A PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809058 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Death