BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 18354406 · Received December 19, 2023

    Report

    Report Number
    18354406
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    October 13, 2023
    Report Date
    October 26, 2023
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DISPOSABLE BLOOD PRESSURE CUFFS HAVE INSUFFICIENT INFLATION AND / OR FAILURE TO INFLATE AND PROVIDE READINGS BEYOND THREE INFLATIONS. THIS PROBLEM HAS BEEN CONSISTENTLY OCCURRING DURING PROCEDURES. CURRENTLY NO ADVERSE PATIENT OUTCOMES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459383 WELCH ALLYN, INC. BLOOD PRESSURE CUFF DXQ WELCH ALLYN, INC. 901044 2020-05-01-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown