BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR

    MDR report key: 19450018 · Received May 31, 2024

    Report

    Report Number
    MW5155701
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Report Date
    May 30, 2024
    Manufacturer
    INTERSURGICAL, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 980 VENTILATOR HAD LOW TIDAL VOLUME. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND FOUND CAUSE TRACED TO NON-MEDTRONIC BREATHING CIRCUIT (INTERSURGICAL PATIENT CIRCUIT) WHICH IS INDEPENDENT OF THE VENTILATOR. 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
    173438 VENTILATOR CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI INTERSURGICAL, INC. 2009000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown