BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 11768130 · Received May 4, 2021

    Report

    Report Number
    1218950-2021-10502
    Event Type
    Death
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO PULL THE LOGS FROM THE EVENT. THE LOGS WERE THEN PARSED THROUGH BY A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS) WHO CONFIRMED THAT THE DATA DURING THE REBOOT WOULD NOT BE STORED WITHIN THE SYSTEM AND THAT IT WOULD BE IMPOSSIBLE TO PROVIDE THE CUSTOMER ANY ADDITIONAL INFORMATION FROM THE EVENT. THE CUSTOMER REBOOTED THE SYSTEM ON PURPOSE TO CLEAR THE KEYBOARD AND MOUSE ISSUE AND DO NOT ALLEGE THE DEVICE WAS RESPONSIBLE FOR THE PATIENTS DEATH THE REPORTED MALFUNCTION WAS CONFIRMED; THE CUSTOMERS KEYBOARD AND MOUSE WERE FROZEN WHICH RESULTED IN THE CUSTOMER NEEDING TO REBOOT THEIR DEVICE. A PATIENT DIED DURING THE REBOOT PROCESS HOWEVER THE DATA FROM THE EVENT IS NOT RETRIEVABLE. THE CUSTOMER WAS PROVIDED A LETTER EXPLAINING THAT THE DATA COULD NOT BE RETRIEVED. THE KEYBOARD AND MOUSE ISSUE WAS RESOLVED BY THE FSE BY UPDATING THE CUSTOMERS SYSTEM FROM C.03.02 TO C.03.04. NO FURTHER INVESTIGATION IS REQUIRED. THE DEVICE REMAINS ONSITE AND IN USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT DIED ON (B)(6) 2021 AFTER THE PATIENT MONITORING SYSTEM WAS REBOOTED TO CLEAR A KEYBOARD AND MOUSE LOCK UP ISSUE. THE CUSTOMER REQUESTED ASSISTANCE PULLING THE LOG DATA FOR THE DEATH DURING THE REBOOT PROCESS .

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DIED ON (B)(6) 2021 AFTER THE PATIENT MONITORING SYSTEM WAS REBOOTED TO CLEAR A KEYBOARD AND MOUSE LOCK UP ISSUE. THE CUSTOMER REQUESTED ASSISTANCE PULLING THE LOG DATA FOR THE DEATH DURING THE REBOOT PROCESS .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664300 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Death