BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 23778413 · Received December 11, 2025

    Report

    Report Number
    23778413
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 1, 2025
    Manufacturer
    SALTER LABS
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POP OFF VALVE HAS LOOSE FIT AND DOESN'T STAY IN PLACE WHEN IN USE DURING NEBULIZER TREATMENT. MANUFACTURER RESPONSE FOR HANDHELD NEBULIZER, EN NEBU TECH NEBULIZER WITH INHALATION AND EXHALATION VALVE (PER SITE REPORTER): EQUIPMENT FAILURE EMAILED TO [REDACTED] ON [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603394 N/A NEBULIZER (DIRECT PATIENT INTERFACE) CAF SALTER LABS 8960-7 (10)NOP040918C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown