BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAL FULL FACE MASK VENTED

    MDR report key: 2761278 · Received September 26, 2012

    Report

    Report Number
    9611451-2012-00673
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLIANT DEVICES ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO RT040 VENTED HOSPITAL FULL FACE MASKS (MASK 1: LOT NO. 100804 SIZE LARGE, MASK 2: LOT NO. 110919 SIZE MEDIUM) WERE RECEIVED AT FISHER & PAYKEL HELATHCARE IN (B)(4) FOR EVALUATION. THE TWO MASKS WERE VISUALLY INSPECTED AND THE DIMENSIONS OF THE PORT CAPS WERE MEASURED. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE OXYGEN PORTS ON THE RETURNED MASKS AND NO PORT CAPS WERE MISSING. THE DIMENSIONS OF ALL PORT CAPS WERE WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBERS PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER. THE OXYGEN PORT CAPS ON THE RT040 MASK ARE DESIGNED TO BE REMOVABLE SO THAT AN OXYGEN LINE CAN BE ATTACHED. THESE PORT CAPS HAVE SUFFICIENT RETENTION TO REMAIN IN PLACE WITH PRESSURE INSIDE OF THE MASK DURING THERAPY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE PORT CAPS ON AN RT040 VENTED HOSPITAL FULL FACE MASK CAME OFF DURING USE ON A PATIENT. THEY FURTHER REPORTED THAT THIS HAS OCCURED WITH FIVE OTHER MASKS IN THE PREVIOUS MONTHS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE PORT CAPS ON AN RT040 VENTED HOSPITAL FULL FACE MASK CAME OFF DURING USE ON A PATIENT. THEY FURTHER REPORTED THAT THIS HAS OCCURRED WITH FIVE OTHER MASKS IN THE PREVIOUS MONTHS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL FULL FACE MASK VENTED MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT040 120518

    Patients

    Seq Age Sex Outcome Treatment
    1