BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO-FIT

    MDR report key: 284394 · Received June 29, 2000

    Report

    Report Number
    2243662-2000-00001
    Event Type
    Malfunction
    Date Received
    June 29, 2000
    Report Date
    June 28, 2000
    Manufacturer
    ACKRAD LABORATORIES INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PARTIAL EXTUBATION OF ENDOTRACHEAL TUBE IN A NEONATAL PT WHILE USING MFR'S NEO-FIT ENDOTRACHEAL TUBE HOLDER. PT REQUIRED RESUSCITATION TO PREVENT SERIOUS INJURY OR DEATH FROM OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO-FIT ENDOTRACHEAL TUBE HOLDER CBH ACKRAD LABORATORIES INC. NA 8222

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention