BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOXIMETER WHOLE BLOOD OXIMETER

    MDR report key: 8572613 · Received May 2, 2019

    Report

    Report Number
    8572613
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 24, 2019
    Report Date
    April 30, 2019
    Manufacturer
    ACCRIVA DIAGNOSTICS HOLDINGS, INC.
    Product Code
    DQA
    UDI-DI
    10711234160022
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO CHECK HEMOGLOBIN DURING CARDIAC CATH UNABLE TO INSERT BLOOD INTO CUVETTE. NURSE MET RESISTANCE SO CUVETTE WAS UNUSABLE MANUFACTURER RESPONSE FOR CUVETTE- WHOLE BLOOD OXIMETER, AVOX (PER SITE REPORTER). CREDITED ACCOUNT FOR 2 BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366998 AVOXIMETER WHOLE BLOOD OXIMETER OXIMETER DQA ACCRIVA DIAGNOSTICS HOLDINGS, INC. C100B 812-109 10711234160022

    Patients

    Seq Age Sex Outcome Treatment
    1