BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 18104564 · Received November 9, 2023

    Report

    Report Number
    1218950-2023-00853
    Event Type
    Death
    Date Received
    November 9, 2023
    Date of Event
    October 1, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 510(K) WAS CORRECTED FROM K153702 TO K183387. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER WHO WAS REQUESTING LOGS DURING TIME OF 07:00 AM ¿ 07:30 AM, FOR A PATIENT INCIDENT OCCURRED ON (B)(6),2023. THE CUSTOMER SPECIFICALLY REQUESTED A LOG REVIEW TO DETERMINE IF THERE WERE ANY ALARMS TURNED OFF (SPECIFICALLY RESPIRATIONS, APNEA, SPO2), WHAT ALARMS WERE ON, AND WHAT ALARMS HAPPENED AROUND THE TIME OF EVENT. THE CAUSE OF DEATH REMAINS UNKNOWN TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE COLLECTED LOGS, CLINICAL AUDIT TRAILS AND EVALUATED THE DEVICE. INITIAL LOG REVIEW AND FUNCTIONAL TESTS FOUND NO MALFUNCTION ON THE PATIENT INFORMATION CENTER IX. THE DEVICE WAS CONFIRMED TO HAVE ALARMED AND WORKED PER SPECIFICATIONS. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) AND CLINICAL SPECIALIST (CS) EVALUATED THE CLINICAL AUDIT LOGS AND DETERMINED THE FOLLOWING: SPO2 ALARMS WERE ON, AS WELL AS TECHNICAL INOP ALARMS WERE PROVIDED FOR SPO2 NO SENSOR, SPO2 SENSOR OFF AND SPO2 NO PULSE. THE CS BELIEVES THAT THE CUSTOMER MUST HAVE THEIR ALARMS SET TO NOT LATCH SINCE THE ALARMS STOP ON THEIR OWN WITHOUT AN ACKNOWLEDGEMENT OF THE ALARM. ALARM FOR RESP LEADS OFF WAS GENERATED AT 7:32:58, AND RESP ALARMS WERE OFF BY DEFAULT. THERE WAS NO APNEA ALARM, AS THE CONFIGURATION FILE REVEALED THAT THE RESP ALARMS WERE OFF BY DEFAULT. THERE WAS NO MALFUNCTION ON THE PATIENT INFORMATION CENTER IX. THE DEVICE WAS CONFIRMED TO HAVE ALARMED AND WORKED PER SPECIFICATIONS. THERE WAS NO APNEA ALARM, AS THE CONFIGURATION FILE REVEALED THAT THE RESPIRATORY ALARMS WERE SET TO OFF BY DEFAULT.

    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

    ADDITIONAL INFORMATION WAS RECEIVED DURING A CALL WITH THE CUSTOMER THAT THEY ARE ALLEGING A FAILURE OF THE APNEA ALARM. THE INTELLIVUE MX800 PATIENT MONITOR IN USE DURING THIS EVENT WAS REPORTED IN MFR REPORT NUMBER 9610816-2023-00641.

    Description of Event or Problem · 0

    THE CUSTOMER REQUESTED LOGS FOR A DECEASED PATIENT. THE PHILIPS TECHNICAL CONSULTANT CONFIRMED THE ALARMS WORKED PER SPECIFICATION AND THE CUSTOMER DID NOT ALLEGE A MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92906 PATIENT INFORMATION CENTER IX CENTRAL MONITORING STATION MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death