BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MR PATIENT CARE LOFLO CANNULA LINE

    MDR report key: 22929688 · Received September 2, 2025

    Report

    Report Number
    22929688
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 11, 2025
    Report Date
    August 22, 2025
    Manufacturer
    SALTER LABS
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    NO HARM TO PATIENT. EQUIPMENT USED IN MRI/HCH SEDATION APPEARS FAULTY - THIS IS THE "MR PATIENT CARE ADULT LOFLO CO2 WITH O2 CANNULAS" MADE BY SALTER LABS. LOT 532217, EXP 1/20/2030. THESE CANNULAS HAVE TWO COMPONENTS - ONE THAT PLUGS INTO THE MONITOR, AND THE OTHER END GOES TO THE O2 CONNECTOR. YOU NEED TO PEEL THE TWO COMPONENTS APART TO SET IT UP. WHEN PEELING APART THE COMPONENTS, THE SIDES OF THE CANNULAS SHRED EVEN WITH NORMAL/USUAL FORCE. WE TRIALED TWO OF THESE CANNULAS SINCE WE BELIEVED THAT THERE WAS OBSTRUCTIVE BREATHING PATTERN BUT THEN WE TRIED BREATHING ON THEM OURSELVES AND THERE WAS NO END TIDAL TRACING. THESE ARE NON-FUNCTIONAL AND NEED TO BE REPLACED FOR USE IN MRI AND PEDI SEDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836755 PHILIPS MR PATIENT CARE LOFLO CANNULA LINE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK SALTER LABS P183271 532217

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male