BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESON 2 NASAL MASK

    MDR report key: 8895767 · Received August 14, 2019

    Report

    Report Number
    9611451-2019-00785
    Event Type
    Injury
    Date Received
    August 14, 2019
    Report Date
    July 25, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    K153505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE COMPLAINT ESON 2 NASAL MASK MODEL IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K153505. METHOD: THE COMPLAINT ESON2 INTERFACE WAS RECEIVED AT F&P NEW ZEALAND FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, VISUAL INSPECTION OF THE COMPLAINT MASK AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: A DOCTOR'S OPINION WAS REQUESTED FROM THE PATIENT; HOWEVER NO CERTIFICATE WAS PROVIDED. A VISUAL INSPECTION OF THE COMPLIANT DEVICE REVEALED THAT THERE WAS NO PHYSICAL DAMAGE OR OBSERVABLE DEFECTS TO THE MASK. A LEAK TEST COULD NOT BE PERFORMED DUE TO HEALTH AND SAFETY REASONS AS THE MASK BASE AND ITS COMPONENTS (INCLUDES A DIFFUSER, NASAL SEAL, AND HEADGEAR) ARE MOLDY, DIRTY AND HAVE A STRONG ODOR. CONCLUSION: WE CANNOT CONCLUSIVELY DETERMINE WHAT CAUSED THE REPORTED EVENT, HOWEVER, WE IDENTIFY THAT THE INTERFACE HAD NO PHYSICAL DAMAGE WHICH MIGHT RESULT IN AN AIR LEAK. THE USER INSTRUCTIONS THAT ACCOMPANY THE INTERFACE ESON2 NASAL MASK STATE: IF YOU ARE EXPERIENCING MASK LEAKS, YOU MAY NEED TO LIFT THE SILICONE SEAL OFF YOUR FACE AND REPOSITION IT AGAIN. THE USER INSTRUCTIONS ALSO CONTAIN THE FOLLOWING WARNING: DISCONTINUE USE AND CONSULT YOUR HEALTHCARE PROVIDER OR PHYSICIAN IF THE FOLLOWING OCCURS: 1. MASK DISCOMFORT OR IRRITATION. 2. ALLERGIC REACTION. ENSURE THE DIFFUSER IS COMPLETELY DRY BEFORE EACH USE.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN GERMANY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT A PATIENT USING ESON 2 NASAL MASK HAD DETERIORATION IN VISION FROM 90% TO LESS THAN 60% WITHIN THE LAST YEAR. IT WAS ALSO REPORTED BY THE DISTRIBUTOR THAT THE PATIENT WAS REQUESTED TO SUBMIT CERTIFICATE/LETTER OF DOCTOR'S OPINION HOWEVER NO CONFIRMATION WAS RECEIVED. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT ESON 2 NASAL MASK MODEL IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K153505. THE COMPLAINT ESON2 NASAL MASK IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE ARE ALSO CURRENTLY IN THE PROCESS OF OBTAINING MORE INFORMATION FROM THE CUSTOMER REGARDING THE EVENT. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT A PATIENT USING ESON 2 NASAL MASK HAD DETERIORATION IN VISION FROM 90% TO LESS THAN 60% WITHIN THE LAST YEAR. IT WAS ALSO REPORTED BY THE DISTRIBUTOR THAT THE PATIENT WAS REQUESTED TO SUBMIT CERTIFICATE/LETTER OF DOCTOR'S OPINION HOWEVER NO CONFIRMATION WAS RECEIVED. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685688 ESON 2 NASAL MASK MASK BZD FISHER & PAYKEL HEALTHCARE LTD ESN2MU NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability