BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-VENTED HOSPITAL FULL FACE MASK

    MDR report key: 6521301 · Received April 26, 2017

    Report

    Report Number
    9611451-2017-00347
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Report Date
    March 27, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    MNT
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT045 NON-VENTED HOSPITAL FULL FACE MASK IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K060044. METHOD: NO COMPLAINT DEVICE WAS RECEIVED AS THE HOSPITAL HAD DISCARDED IT PRIOR TO REPORTING THE EVENT. RESULTS: WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE HOSPITAL. THE RT045 NON-VENTED HOSPITAL FULL FACE MASK FEATURES A MASK BASE, SEAL, AND HEADGEAR. THE MASK IS INTENDED TO ENABLE NON-INVASIVE POSITIVE PRESSURE VENTILATION (NPPV) THERAPY (CPAP OR BI-LEVEL) TO BE DELIVERED TO SPONTANEOUSLY BREATHING ADULT PATIENTS WITH RESPIRATORY INSUFFICIENCY OR RESPIRATORY FAILURE AND HAVE BEEN PRESCRIBED NPPV. THE MASKS ARE TO BE FITTED AND THERAPY MAINTAINED BY TRAINED MEDICAL PRACTITIONERS IN A HOSPITAL/INSTITUTIONAL ENVIRONMENT WITH PATIENT MONITORING IN PLACE. OUR USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE RT045 NON-VENTED HOSPITAL FULL FACE MASK. IT ALSO STATES THE FOLLOWING: INSPECT THE MASK FOR DAMAGE. DISCARD THE MASK IF ANY PARTS ARE BROKEN OR IF THE SEAL IS TORN. VERIFY THAT THE THERAPY DEVICE (I.E. VENTILATOR OR FLOW SOURCE) INCLUDING ALL ALARMS AND SAFETY SYSTEMS ARE FUNCTIONING CORRECTLY AND THAT IT IS SUPPLYING THE CORRECT PRESSURE(S). ENSURE ADEQUATE PATIENT MONITORING IS IN PLACE. VERIFY THAT THE THERAPY DEVICE, INCLUDING ALARMS AND SAFETY SYSTEMS, ARE FUNCTIONING CORRECTLY PRIOR TO USE. THE MASK MUST BE FITTED AND THERAPY ESTABLISHED BY AN APPROPRIATELY TRAINED MEDICAL PRACTITIONER OR CARE PROVIDER. THIS MASK MAY ONLY BE USED IN A HOSPITAL OR CLINICAL SETTING WHERE THE PATIENT IS ADEQUATELY MONITORED BY TRAINED MEDICAL STAFF. FAILURE TO MONITOR THE PATIENT MAY RESULT IN LOSS OF THERAPY, SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE RT045 NON-VENTED HOSPITAL FULL FACE MASK HEADGEAR WAS COMING APART. THE SUBJECT MASK WAS USED FOR THREE DAYS PRIOR TO THE REPORTED EVENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303520 NON-VENTED HOSPITAL FULL FACE MASK MNT MNT FISHER & PAYKEL HEALTHCARE LTD RT045 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1