BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20182360 · Received September 10, 2024

    Report

    Report Number
    1218950-2024-00640
    Event Type
    Death
    Date Received
    September 10, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 25, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND RETRIEVED AND PROVIDED THE CUSTOMER WITH THE CLINICAL AUDIT LOGS FOR THE REQUESTED TIME PERIOD. A PHILIPS REMOTE CLINICAL SPECIALIST (RCS) WAS ADDED TO THE CALL. DATA WAS REVIEWED DURING THE CALL. THE RSE REMOTED INTO THE PATIENT INFORMATION CENTER IX (PICIX) AND NOTED YELLOW LEVEL ECG ALARMS OFF AT APPROXIMATELY 0616 HOURS AND MULTIPLE SPO2 ALARMS, AS WELL. THE CUSTOMER DECLINED TO HAVE ONSITE SUPPORT BY A PHILIPS FIELD SERVICE ENGINEER. 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.

    Additional Manufacturer Narrative · 0

    A PHILPS REMOTE SERVICE ENGINEER (RSE) AND A PHILIPS REMOTE CLINICAL SUPPORT (RCS) REPRESENTATIVE SPOKE WITH THE CUSTOMER. THE RSE RETRIEVED THE CLINICAL AUDIT LOGS AND PROVIDED THESE TO THE CUSTOMER. THE RSE AND RCS ASSISTED THE CUSTOMER IN REVIEWING LOG INFORMATION AND IDENTIFIED YELLOW LEVEL ECG ALARMS AND SPO2 ALARMS. THE RCS PROVIDED INFORMATION TO THE CUSTOMER ON HOW TO SEARCH THE PATIENT DATA BY THE PATIENT MEDICAL RECORD NUMBER. THE CUSTOMER INDICATED THERE WAS NO PRODUCT MALFUNCTION AND DECLINED ONSITE SERVICE. THE LOGS WERE PROVIDED TO A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) FOR TECHNICAL INVESTIGATION. THE PSE VERIFIED THAT ON (B)(6) 2024, ¿ECG LEADS OFF¿ (CYAN INOP) STARTED AT 05:06:32 AND THEN IT ESCALATED TO ¿!!ECG LEADS OFF¿ (YELLOW INOP) AT 05:06:36. THIS ESCALATED ¿!!ECG LEADS OFF¿ (YELLOW INOP) ENDED AT 06:16:50. THE REPORTED PROBLEM WAS NOT CONFIRMED. INFORMATION WAS PROVIDED TO THE CUSTOMER TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CUSTOMER REQUESTED ASSISTANCE OBTAINING CLINICAL AUDIT LOGS AFTER A PATIENT DEATH. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE NURSE MANAGER REQUESTED VERIFICATION IF LEADS OFF ALARMS OCCURRED FOR THIS PATIENT BEING MONITORED ON TELEMETRY. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297015 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death