BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE OXIMETER SENSOR

    MDR report key: 17682514 · Received September 1, 2023

    Report

    Report Number
    MW5145125
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 29, 2023
    Manufacturer
    APK TECHNOLOGY CO., LTD.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPO2 READING LOW. IT WAS NOTED THAT THE SPO2 WAS READING LOWER THAN EXPECTED ON PTS. IT WAS RECHECKED WITH ANOTHER PULSE OXIMETER THAT GAVE A READING MORE IN LINE WITH THE PT'S PRESENTATION AND SHOWED A SIGNIFICANT DIFFERENCE. THE EXPECTED VARIANCE WAS GREATER THAN 10%. COMPLETED IN HOSPITAL COMPARING WITH ANOTHER TRUSTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870006 PULSE OXIMETER SENSOR OXIMETER DQA APK TECHNOLOGY CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown