BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAL NON-VENTED FULL FACE MASK

    MDR report key: 6459403 · Received April 5, 2017

    Report

    Report Number
    9611451-2017-00304
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 4, 2017
    Report Date
    March 6, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CBK
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT046 HOSPITAL NON-VENTED 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 K083122. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL TO DETERMINE IF THE COMPLAINT RT046 MASKS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR EVALUATION. DEVICES WERE DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT046 HOSPITAL NON-VENTED 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 K083122. METHOD: A REQUEST WAS MADE FOR THE RETURN OF THE COMPLAINT DEVICE, HOWEVER THE CUSTOMER HAD ALREADY DISCARDED THE COMPLAINT DEVICE. RESULTS: WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE HOSPITAL. THE RT046 HOSPITAL NON-VENTED 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 RT046 HOSPITAL NON-VENTED 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. DEVICES WERE DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE "HEADGEAR STITCHING BECAME UNDONE" ON TWO RT046 NON VENTED HOSPITAL FULL FACE MASKS DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE "HEADGEAR STITCHING BECAME UNDONE" ON TWO RT046 NON VENTED HOSPITAL FULL FACE MASKS DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244081 HOSPITAL NON-VENTED FULL FACE MASK CBK CBK FISHER & PAYKEL HEALTHCARE LTD RT046 2100083287

    Patients

    Seq Age Sex Outcome Treatment
    1