BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAK

    MDR report key: 510827 · Received January 22, 2004

    Report

    Report Number
    MW1031035
    Event Type
    Malfunction
    Date Received
    January 22, 2004
    Date of Event
    January 20, 2004
    Report Date
    January 22, 2004
    Manufacturer
    UNOMEDICAL, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEVER USED ON A PT. ANESTHESIA CIRCUITS OPENED/NEW CASE. ENCLOSED CIRCUIT IN SEALED PLASTIC. OPENED WITH "LARGE BUG" IN ONE FILTER AND "BUG REMNANTS" IN OTHER FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAK ANESTHESIA CIRCUITS CAI UNOMEDICAL, INC. ANES BREATHING CIRCUITS ADULT 40" C-157-C 03-28

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other