BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTCARE CONNECT PREMIUM PLUS - TIER D

    MDR report key: 24757348 · Received April 1, 2026

    Report

    Report Number
    1316463-2026-00018
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 14, 2026
    Manufacturer
    WELCH ALLYN INC
    Product Code
    BZG
    UDI-DI
    00732094301212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE REPORTED INCIDENT, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT INCORRECT REPORTS WERE AUTO ATTACHING TO THE WRONG PATIENT FILE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610380 SMARTCARE CONNECT PREMIUM PLUS - TIER D SPIROMETER, DIAGNOSTIC BZG WELCH ALLYN INC CPWS 00732094301212

    Patients

    Seq Age Sex Outcome Treatment
    1