BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPO2 CABLE

    MDR report key: 22068929 · Received May 22, 2025

    Report

    Report Number
    22068929
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    March 27, 2025
    Report Date
    May 15, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN 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

    NURSE CONNECTED FINGER SENSOR TO SPO2 [OXYGEN SATURATION OF PERIPHERAL OXYGEN] CABLE AND DID NOT RECEIVE A READING. SPO2 ADAPTER CABLE REPLACED AND RECEIVED SPO2 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
    1070424 SPO2 CABLE OXIMETER DQA PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN) 1224

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Unknown