BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOXIMETER WHOLE BLOOD OXIMETER

    MDR report key: 9976870 · Received April 20, 2020

    Report

    Report Number
    9976870
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    February 4, 2020
    Report Date
    April 13, 2020
    Manufacturer
    ACCRIVA DIAGNOSTICS HOLDINGS, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVOXIMETER CURVETTE WOULD NOT PROPERLY FILL WITH BLOOD. HOLE TO ALLOW BLOOD IN APPEARS BLOCKED. THIS IS THE SECOND OCCURRENCE WITH THIS LOT OF CURVETTES. I JUST USED ANOTHER ONE AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442478 AVOXIMETER WHOLE BLOOD OXIMETER OXIMETER DQA ACCRIVA DIAGNOSTICS HOLDINGS, INC. C100B 7102692

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA