BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 18181831 · Received November 21, 2023

    Report

    Report Number
    1218950-2023-00859
    Event Type
    Death
    Date Received
    November 21, 2023
    Date of Event
    October 19, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REQUESTED ASSISTANCE EXTRACTING LOGS FROM THE PIC FOR THE TIMEFRAME (B)(6)2023 DURING WHICH A PATIENT PASSED AWAY. THERE WAS NO SPECIFIC PRODUCT MALFUNCTION ALLEGATION MADE AGAINST THE PIC. THE REMOTE CLINICAL SUPPORT (RCS) EXPLAINED TO THE CUSTOMER THAT THE PATIENT DATA IS STORED FOR UP TO SEVEN DAYS ON THE SYSTEM DURING THE PATIENT STAY AND UNTIL THEIR DISCHARGE FROM THE HOSPITAL, HENCE THE PATIENT'S HISTORY WOULD HAVE BEEN PURGED AT THIS TIME. THE FIELD ENGINEER (FSE) RETRIEVED THE UNIT CLINICAL AUDIT LOGS, PICIX LOGS AND BEDSIDE CONFIGURATION. FSE WORKED WITH HOSPITAL BIOMED TO TEST BEDSIDE ALARMS. THE RESULTS VERIFIED ECG AND SP02 ALARMS WORKING AT PIC IX AND BEDSIDE. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE CONFIRMED. NO FURTHER ACTION IS NEEDED AT THIS TIME. THE UNIT IS FUNCTIONING CORRECTLY AND AS EXPECTED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A PATIENT DEATH. IT IS UNKNOWN IF THERE WAS A PRODUCT MALFUNCTION THAT CONTRIBUTED TO THE PATIENT DEATH. CUSTOMER REQUESTED ASSISTANCE GATHERING THE CLINICAL LOGS RELATED TO THE PATIENT DEATH. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS A REPORT OF PATIENT HARM.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A PATIENT DEATH. IT IS UNKNOWN IF THERE WAS A PRODUCT MALFUNCTION THAT CONTRIBUTED TO THE PATIENT DEATH. CUSTOMER WAS UNABLE TO RETRIEVE LOG DATA TO INVESTIGATE THE PATIENT DEATH AND REQUESTED ASSISTANCE GATHERING THE LOGS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS A REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068904 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death