BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 20309006 · Received September 26, 2024

    Report

    Report Number
    20309006
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 17, 2024
    Report Date
    September 24, 2024
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HLI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE U SHAPED CRADLE WITH DIODES PART #105062 IN A WALL MOUNTED OPHTHALMOSCOPE THAT HOLDS THE SCOPE AND TURNS THE LIGHT ON AND OFF WAS BROKEN. THE CRADLE HAS BEEN REPLACED ON THIS OPHTHALMOSCOPE 6 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239705 WELCH ALLYN, INC. OPHTHALMOSCOPE, AC-POWERED HLI WELCH ALLYN, INC. 777

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown