BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOSPITAL FULL FACE MASK NON-VENTED

    MDR report key: 2200403 · Received August 11, 2011

    Report

    Report Number
    9611451-2011-00469
    Event Type
    Death
    Date Received
    August 11, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 12, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    MNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT041 HOSPITAL FULL FACE NON-VENTED MASK IS NOT EXPECTED TO BE RETURNED TO FPH (B)(4), AS THE MEDICAL CENTRE HAS RETAINED IT FOR THEIR OWN INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION AND ADDITIONAL INFORMATION PROVIDED BY THE MEDICAL CENTRE. THE MEDICAL CENTRE REPORTED THAT THE PATIENT INITIALLY USED THE RT041 MASK WITH THE PURITAN & BENNET 840 VENTILATOR FROM 3:30PM ON (B)(6) 2011. AFTER FOUR HOURS, THE MEDICAL STAFF DECIDED TO PUT THE PATIENT ON THE RESPIRONICS VISION BIPAP VENTILATOR WITH A SINGLE LIMB CIRCUIT WITH NO BUILT-IN EXHALATION PORT; HOWEVER, THE PATIENT REMAINED ON THE RT041 MASK. THE PATIENT WAS ON THIS SET-UP UNTIL 7:30AM THE FOLLOWING MORNING. ADDITIONAL INFORMATION RECEIVED FROM THE MEDICAL CENTRE REVEALED THAT AFTER THE RT041 MASK WAS REMOVED, THE PATIENT "CODED". THE MEDICAL CENTRE CONFIRMED THAT THE PATIENT DIED BUT DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE EXACT TIME, CIRCUMSTANCES, OR CAUSE OF DEATH. AN FPH CLINICAL PRODUCT SPECIALIST CONTACTED THE MEDICAL CENTRE AND BASED ON THE INFORMATION PROVIDED, WE UNDERSTAND THAT THE MASK HAD NO DEFECT AND WAS FUNCTIONING AS INTENDED. IT WAS ALSO REPORTED BY THE MEDICAL CENTRE'S DEPARTMENT HEAD TO AN FPH CLINICAL PRODUCT SPECIALIST THAT THE INCORRECT USE OF NON-VENTED MASK WITH PASSIVE EXHALATION VENTILATOR SYSTEM (I.E. SYSTEM REQUIRING A VENTED MASK) MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT041M HOSPITAL FULL FACE NON-VENTED MASK INDICATE IN PICTORIAL FORM THE CORRECT SET-UP AND USE/FITTING OF THE MASK, AND STATE THE FOLLOWING: "THIS MASK DOES NOT INCLUDE AN ANTI-ASPHYXIATION VALVE THAT WOULD ALLOW A PATIENT TO BREATH IN CASE OF THERAPY DEVICE FAILURE." "THE MASK SHOULD ONLY BE USED ON DUAL LIMB VENTILATION SYSTEMS OR WITH AN ADDITIONAL BIAS FLOW COMPONENT." "THIS MASK MAY ONLY BE USED IN A HOSPITAL OR CLINICAL SETTING WHERE THE PATIENT IS ADEQUATELY MONITORED BY TRAINED MEDICAL STAFF." "THE MASK MUST BE USED WITH VENTILATORS THAT HAVE ADEQUATE ALARMS AND SAFETY SYSTEMS FOR VENTILATOR FAILURE." AN FPH CLINICAL PRODUCT SPECIALIST IS CURRENTLY WORKING WITH THE MEDICAL CENTRE TO CARRY OUT A TRAINING SESSION WITH THE MEDICAL STAFF TO REINFORCE THE SET-UP INSTRUCTIONS FOR THE RT041 HOSPITAL FULL FACE NON-VENTED MASK.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED THE FOLLOWING INVOLVING AN RT041M HOSPITAL FULL FACE NON-VENTED MASK: THE PATIENT INITIALLY WAS PUT ON AN RT041M NON-VENTED MASK WITH A PURITAN & BENNETT 840 VENTILATOR STARTING FROM 3:30PM ON (B)(6) 2011. AT 7:30PM, THE PATIENT WAS SWITCHED TO A RESPIRONICS VISION BIPAP WITH A SINGLE LIMB CIRCUIT WITH NO BUILT-IN EXHALATION PORT, BUT STILL USED THE SAME RT041M NON-VENTED MASK. THE PATIENT WAS ON THIS SETUP UNTIL 7:30AM THE FOLLOWING MORNING. AFTER THE MASK WAS REMOVED, THE PATIENT "CODED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL FULL FACE MASK NON-VENTED MNT MNT FISHER & PAYKEL HEALTHCARE LIMITED RT041M 110303

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PURITAN & BENNETT 840 VENTILATOR| RESPIRONICS VISION BIPAP| SINGLE LIMB CIRCUIT (NO BUILT-IN EXHALATION PORT)