BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPO2 CABLE

    MDR report key: 21738453 · Received April 1, 2025

    Report

    Report Number
    21738453
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 14, 2025
    Report Date
    March 28, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PHILIPS PULSE OXIMETER ADAPTER CABLE ATTACHED TO SENSOR/FINGER PROBE THAT HAD BEEN APPLIED TO THE PATIENT AND CONNECTED TO THE MACHINE. MACHINE NOTED "SENSOR NOT FOUND." NEW FINGER PROBE APPLIED AND RECEIVED SAME ERROR MESSAGE. CABLE EXCHANGED FOR NEW CABLE AND MACHINE REGISTERED SPO2 [SATURATION OF PERIPHERAL OXYGEN] READING. THIS RESULTED IN A DELAY IN PATIENT CARE, NO KNOWN HARM TO THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165467 SPO2 CABLE OXIMETER DQA PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH M1943AL 1224

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown