BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARE-FUSION

    MDR report key: 1741388 · Received June 24, 2010

    Report

    Report Number
    MW5016517
    Event Type
    Other
    Date Received
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    CAREFUSION RESPIRATORY CARE
    Product Code
    BYF
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT O2 LEVELS AND DE-SATURATION OCCURRING AS THE RESULT OF THE EQUIPMENT -CARE FUSION-VENTURI MASK DEVICES #001255 - BEING INCORRECTLY ASSEMBLED FOR USE IN PT CARE. THE ISSUE WAS IDENTIFIED IN THE PACKAGING WHICH SAYS "ATTENTION: SEE INSTRUCTIONS FOR USE" BUT THERE ARE NO INSTRUCTIONS IN THE PACKAGES. COMPANY REP ACKNOWLEDGED THAT THE INSTRUCTIONS SHOULD HAVE BEEN IN THE PACKAGING. INSTRUCTIONS WERE SENT TO MMC BY THE COMPANY. PRODUCT COMPLAINT SUBMITTED BY COMPANY REP (B)(4). RESPIRATORY THERAPY ASSESSED ALL PTS WITH THIS THERAPY CURRENTLY IN PLACE TO CONFIRM CORRECT ASSEMBLY OF EACH UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE-FUSION CARE-FUSION VENTURI MASK DEVICES BYF CAREFUSION RESPIRATORY CARE 001255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other