BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BLOOD PRESSURE CUFF

    MDR report key: 18236948 · Received November 30, 2023

    Report

    Report Number
    18236948
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 20, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    DXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AS PATIENT WAS GETTING TRANSFUSED WITH AN MTE (MASSIVE TRANSFUSION EVENT PROTOCOL), BP (BLOOD PRESSURE) CUFF REQUIRED MULTIPLE RE-CYCLES AFTER TIMING OUT BEFORE GIVING A BLOOD PRESSURE. SOME PRESSURES WERE LOW (80S/40S) AND SOME WERE WITHIN NORMAL LIMITS. ULTIMATELY, AN ARTERIAL LINE WAS PLACED TO MORE CLOSELY MONITOR PATIENT'S BLOOD PRESSURES DURING ACTIVE RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939720 DISPOSABLE BLOOD PRESSURE CUFF BLOOD PRESSURE CUFF DXQ MEDLINE INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Female