BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MICROSTREAM EXTENSION

    MDR report key: 21018214 · Received December 26, 2024

    Report

    Report Number
    21018214
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 18, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON ENTERING PATIENT'S ROOM, PHILIPS MONITOR WAS NOT READING ETCO2. NEW ETCO2 CUVETTE PLACED IN LINE, WITH NO RESULTS. X3 HAD A NEW BATTERY PLACED ON (B)(6) 2024 @2130. NEW ETCO2 POD OBTAINED TO USE IN PATIENT ROOM AND FUNCTIONING CORRECTLY. NO ADVERSE AFFECT ON PATIENT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625686 INTELLIVUE MICROSTREAM EXTENSION ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH INTELLIVUE MICROSTREAM EXTENSION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female