BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE

    MDR report key: 25250016 · Received May 21, 2026

    Report

    Report Number
    1316463-2026-00303
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    BZG
    UDI-DI
    00732094325386
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT THE DIAGNOSTIC CARDIOLOGY SUITE HAD INCORRECT PATIENT INFORMATION PULLED IN WHEN TAKING EXAM THROUGH VERADIGM/ALLSCRIPTS. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295881 WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE SPIROMETER, DIAGNOSTIC BZG BAXTER HEALTHCARE CORPORATION 901128 N/A 00732094325386

    Patients

    Seq Age Sex Outcome Treatment
    1