BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELISA VENTILATOR

    MDR report key: 22795074 · Received August 13, 2025

    Report

    Report Number
    MW5174428
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 29, 2025
    Manufacturer
    LOEWENSTEIN MEDICAL AMERICAS CORP.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SYSTEM FAILURE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866237 ELISA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK LOEWENSTEIN MEDICAL AMERICAS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown