BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAL FULL FACE MASK NON-VENTED

    MDR report key: 3053912 · Received April 11, 2013

    Report

    Report Number
    9611451-2013-00261
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS AND DEVICE MANUFACTURING DATE: 120822 - 22 AUGUST 2012; 121016 - 16 OCTOBER 2012. THE COMPLAINT RT040M MASKS ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AS THEY ARE NOT AVAILABLE. OUR INVESTIGATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND THE INFORMATION PROVIDED BY THE CUSTOMER. IT WAS REPORTED THAT THE PORT CAPS KEPT "POPPING OFF" FROM THE RT040M MASKS AND A FEW PATIENTS WERE AGITATED WHILE USING THE MASK. THE HOSPITAL ALSO REPORTED THAT NO DAMAGE WAS OBSERVED ON THE COMPLAINT MASKS. IT IS POSSIBLE THAT THE PATIENTS WERE PULLING THE CAPS OFF FROM THE MASK AND THE PORTS WERE LOST IF THEY WERE COMPLETELY DETACHED. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE IF THE PORT CAPS OR PORTS WERE OUT OF SPECIFICATION OR DAMAGED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE PORT CAPS OF TWO RT040 HOSPITAL FULL FACE NON-VENTED MASKS WERE "POPPING OFF". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154888 HOSPITAL FULL FACE MASK NON-VENTED MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT040 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1