BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30

    MDR report key: 18229141 · Received November 29, 2023

    Report

    Report Number
    18229141
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    August 6, 2023
    Report Date
    September 29, 2023
    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

    PULSE OXIMETER ON MONITOR DOES NOT FUNCTION PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920512 EARLYVUE VS30 OXIMETER DQA PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH EARLYVUE VS30 VITALS MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown