BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPO2 CABLE

    MDR report key: 21738398 · Received April 1, 2025

    Report

    Report Number
    21738398
    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

    SPO2 [SATURATION OF PERIPHERAL OXYGEN] SENSOR APPLIED TO PATIENT AND CONNECTED TO PHILIPS ADAPTOR CABLE WHICH WAS ATTACHED TO THE MACHINE. MACHINE UNABLE TO PROVIDE SPO2 READING. CABLE REPLACED AND SPO2 READING PROVIDED. INITIAL CABLE FAILED TO PRODUCE A READING. THIS RESULTED IN A DELAY IN CARE TO THE PATIENT, NO KNOWN PATIENT HARM AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041471 SPO2 CABLE OXIMETER DQA PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH M1943AL 1224

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown