BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20062668 · Received August 26, 2024

    Report

    Report Number
    1218950-2024-00602
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    July 23, 2024
    Report Date
    October 8, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K183387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED. THE INVOLVED INTELLIVUE MX100 IS REPORTED UNDER MFR REPORT NUMBER: 9610816-2024-00549. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Additional Manufacturer Narrative · 0

    A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED PROVIDED AUDIT LOGS FROM THE PIC IX. PER THE PSE, THE EVENT BEGAN (B)(6) 2024 AT 05:40AM. THAT TIMESTAMP FALLS BETWEEN THE TIME WHERE THE USER TURNED OFF THE SPO2 ALARMS AT 11:29:36AM ON (B)(6) 2024 AND THEN TURNED SPO2 ALARMS BACK ON AT 7:03:08AM ON (B)(6) 2024, AS SEEN IN THE AUDIT LOG. (B)(6) 2024 18:03:49 UCMC CCD 10-033 PULSE - PULSE ALARMS FROM ON TO OFF MON10033 ALARM ON/OFF. (B)(6) 2024 18:03:49 UCMC CCD 10-033 PULSE - ECG/ARRHY ALARMS FROM OFF TO ON MON10033 ALARM ON/OFF. (B)(6) 2024 17:56:46 UCMC CCD 10-033 P - ALARMS ON MON10033 ALARM ON/OFF. (B)(6) 202417:56:46 UCMC CCD 10-033 SPO2 - ALARMS ON MON10033 ALARM ON/OFF. (B)(6) 2024 17:56:43 UCMC CCD 10-033 PULSE - PULSE ALARMS FROM OFF TO ON MON10033 ALARM. ON/OFF. (B)(6) 2024 17:56:43 UCMC CCD 10-033 PULSE - ECG/ARRHY ALARMS FROM ON TO OFF MON10033 ALARM. ON/OFF. (B)(6) 2024 17:56:43 UCMC CCD 10-033 PULSE - PULSE ALARMS OFF MON10033 ALARM. ON/OFF. (B)(6) 2024 17:56:43 UCMC CCD 10-033 PULSE - ECG/ARRHY ALARMS ON MON10033 ALARM. ON/OFF. (B)(6) 2024 07:04:28 UCMC CCD 10-033 PULSE - PULSE ALARMS FROM ON TO OFF MON10033 ALARM. ON/OFF. (B)(6) 2024 07:04:28 UCMC CCD 10-033 PULSE - ECG/ARRHY ALARMS FROM OFF TO ON MON10033 ALARM. ON/OFF. (B)(6) 2024 07:03:08 UCMC CCD 10-033 SPO2 - ALARMS ON MON10033 ALARM. ON/OFF. (B)(6) 2024 07:03:08 UCMC CCD 10-033 P - ALARMS ON MON10033 ALARM. ON/OFF. (B)(6) 2024 07:03:05 UCMC CCD 10-033 PULSE - PULSE ALARMS ON MON10033 ALARM. ON/OFF. (B)(6) 2024 07:03:05 UCMC CCD 10-033 PULSE - ECG/ARRHY ALARMS OFF MON10033 ALARM. ON/OFF. (B)(6) 2024 06:45:57 UCMC CCD 10-033 PULSE - ECG/ARRHY ALARMS ON MON10033 ALARM. ON/OFF. (B)(6) 2024 06:41:26 UCMC CCD 10-033 PULSE - ECG/ARRHY ALARMS ON MON10033 ALARM. ON/OFF. (B)(6) 2024 06:41:19 UCMC CCD 10-033 PULSE - ECG/ARRHY ALARMS ON MON10033 ALARM. ON/OFF. (B)(6) 2024 11:29:36 UCMC CCD 10-033 SPO2 - ALARMS OFF MON10033 ALARM. ON/OFF. BASED ON THE INFORMATION AVAILABLE AND THE REVIEW OF THE AUDIT LOGS, THE CAUSE OF THE REPORTED PROBLEM WAS THE USERS TURNING OFF THE SPO2 ALARMS. THE REPORTED PROBLEM OF AN ALARM FAILURE WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S SPO2 READING DISPLAYED AS LOW AS 40% BUT NO ALARM WAS GENERATED, WHICH LED TO A DELAY IN CARE OF UNKNOWN DURATION. THE PATIENT WENT INTO CARDIAC ARREST AND WAS TRANSFERRED TO THE ICU. AFTER REVIEWING THE CLINICAL AUDIT LOG, IT WAS DETERMINED THE SPO2 ALARMS WERE TURNED OFF AT THE CENTRAL STATION BY THE END USER. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS A REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481721 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention