BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1905262 · Received November 22, 2010

    Report

    Report Number
    9611451-2010-00677
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FISHER & PAYKEL HEALTHCARE HAS NOT RECEIVED THE COMPLAINT RT040 FULL FACE MASK. WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED FAULT. A LOT NUMBER WAS NOT PROVIDED THUS A LOT CHECK COULD NOT BE PERFORMED. AN RT040 MASK HAS HEADGEAR THAT CAN BE ADJUSTED AT BOTH THE FOREHEAD AND THE BASE OF THE HEAD TO ENSURE THE BEST POSSIBLE FIT. A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE HAS CARRIED OUT INSERVICE TRAINING SESSIONS WITH THE HEALTHCARE FACILITY STAFF IN RELATION TO THE MASK SIZING AND FITTING PROCEDURES FOR THE FULL FACE MASKS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A PATIENT WAS UNABLE TO GET A GOOD FIT AND SEAL ON AN RT040 FULL FACE MASK. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LIMITED RT040 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1