BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE X3

    MDR report key: 18863283 · Received March 8, 2024

    Report

    Report Number
    9610816-2024-00125
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    December 28, 2023
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838082588
    PMA / PMN Number
    K171801
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE MASIMO SPO2 ADAPTER CABLE. THE REPORTED PROBLEM WAS CONFIRMED. THE ADAPTER CABLES WERE PICKED UP AT THE CUSTOMER SITE BY A MASIMO REPRESENTATIVE FOR ANALYSIS. MASIMO STATED IN THEIR PRE-LIMINARY INVESTIGATION RESULT THAT SEVERAL OF THE ANALYZED ADAPTER CABLES SHOW A CHEMICAL CONTAMINATION OF THE CONNECTORS (SENSOR SIDE & MONITOR SIDE). MASIMO ADVISED THAT IT COULD BE CAUSED BY INAPPROPRIATE DECONTAMINATION OF THE ADAPTER CABLES. MASIMO WILL PROVIDE NEW ADAPTER CABLES TO THE CUSTOMER AND TEACH THEM TO CLEAN THE ADAPTER CABLES CORRECTLY . IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. REPORTER PHONE NUMBER: (B)(6). REPORTING INSTITUTION PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A SATURATION PROBLEM IN WHICH THE SPO2 DISAPPEARED ON THE MONITOR; THEREFORE, SPO2 MONITORING WAS UNAVAILABLE THE THERE WAS A DELAY IN EXTUBATION. THE MONITOR WAS POWER CYCLED, AND CABLES WERE CHANGED WITH NO RESOLUTION. 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
    2195874 INTELLIVUE X3 INTELLIVUE X3 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867030 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Other