BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX

    MDR report key: 17056367 · Received June 2, 2023

    Report

    Report Number
    2027541-2023-00001
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    April 26, 2023
    Report Date
    June 30, 2023
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    UDI-DI
    0570069393839
    PMA / PMN Number
    K051804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 14TH, 2023, THE CUSTOMER PROVIDED THE PRODUCT INFORMATION: " FAILING PART: ABL80 FLEX BASIC SENSOR CASSETTE P/N: 945-785, L/N: 350163, S/N: (B)(6)", IN WHICH CONFIMING THAT THE PRODUCT IS NOT BEING MARKETED IN THE US. THEREFORE, IT IS CONLUDED THAT THIS CASE IS NOT SUBJECT FOR MDR REQUIREMENTS.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, THE CUSTOMER EXPERIENCED DISCREPANT RESULT ON PO2 WHEN USING AN ABL80 FLEX ANALYZER BASIC VERSION 304055. TWO BLOOD PRESSURE MEASUREMENTS WERE COLLECTED, THE FIRST MEASUREMENT WAS 93 MMHG, AND THE SECOND MEASUREMENT WAS 71 MMHG. BOTH MEASUREMENTS WERE TAKEN WITH TWO SAMPLES OF BLOOD. IT HAS NOT BEEN SPECIFIED WHICH MEASUREMENT IS CONSIDERED DISCREPANT. NO MATTER WHETHER THIS IS CONSIDERED AS A DISCREPANT FALSE HIGH (FH) OR FALSE LOW (FL) PO2 MEASUREMENT ON ABL80, THIS COULD POTENTIALLY LEAD TO HARM OF SEVERITY 4 (PERMANENT (SERIOUS)) FOR NEWBORNS ACCORDING TO INTERNAL ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218296 ABL80 FLEX ABL80 FLEX BLOOD-GASES ANALYZER CHL SENDX MEDICAL, INC. 393-839 0570069393839

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown