BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9611451-2008-00014

    MDR report key: 992927 · Received February 9, 2008

    Report

    Report Number
    9611451-2008-00014
    Event Type
    Malfunction
    Date Received
    February 9, 2008
    Date of Event
    January 7, 2008
    Report Date
    January 10, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE. METHOD - NO INFORMATION TO DATE. RESULTS - INVESTIGATION STILL UNDERWAY. OUR RECORDS INDICATE THAT ONE OTHER COMPLAINT (TOTAL TWO COMPLAINTS) OF THIS NATURE HAS BEEN RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION - NO CONCLUSION CAN BE MADE AT THIS TIME. ADD'L LOT# 071031.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT SIX RT040 FULL FACE MASKS 'ARE APART IN THE PACKAGE WON'T BOLD SEAL'. WE BELIEVE THIS TO MEAN THE MASK CUSHION OF THE RT040 FULL FACE MARK SEPARATED FROM THE MASK FRAME. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MNT FISHER & PAYKEL HEALTHCARE, LTD. RT040 071018

    Patients

    Seq Age Sex Outcome Treatment
    1