BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAL NASAL MASK

    MDR report key: 2387282 · Received December 22, 2011

    Report

    Report Number
    9611451-2011-00825
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Report Date
    November 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURER DATE: LOT 110726 - 07/26/2011; LOT 110823 - 08/23/2011; LOT 110824 - 08/24/2011. METHOD: THE 35 COMPLAINT RT042 MASKS HAVE BEEN RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THE SEAL OF 5 COMPLAINT MASKS [LOT 110726 (1), 110824 (3), UNKNOWN (1)] SEPARATED FROM THE BASE AT THE BOTTOM PART OF THE MASK. NO DAMAGE WAS FOUND TO THE SEAL OR BASE. NO FAULT WAS FOUND WITH THE REMAINING 30 MASKS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOTS 110726, 110823 AND 110824. CONCLUSION: THE NASAL MASK HAS A HARD PLASTIC BASE WITH A SILICONE SEAL ENCLOSING FOAM AROUND THE OUTER EDGE OF THE BASE TO SEAL ONTO THE PATIENT. THE SEAL IS HELD ONTO THE BASE OF THE MASK BY A COMBINATION OF SILICONE CLIPS WITH AN INTERFERENCE FIT. TO REMOVE A PROPERLY FITTED SEAL REQUIRES EXCESSIVE FORCE. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE, HOWEVER IT IS POSSIBLE THAT INCORRECT OR POOR ASSEMBLY BY THE OPERATOR ON THE PRODUCTION LINE CONTRIBUTED TO A WEAK SEAL. AWARENESS TRAINING WAS GIVEN TO PRODUCTION LINE STAFF TO ENSURE OUR STANDARD OPERATING PROCEDURES ARE BEING FOLLOWED CORRECTLY AND TO PREVENT A RECURRENCE OF THIS EVENT. THE SEAL OR CUSHION CAN ALSO COME APART IF SUFFICIENT FORCE OR PULLING IS APPLIED DURING USE. ALL RT042 NASAL MASKS ARE VISUALLY INSPECTED PRIOR TO LEAVING PRODUCTION, ANY THAT FAIL THIS TEST ARE REJECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURER DATE: LOT 110726 - 07/26/2011; LOT 110823 - 08/23/2011; LOT 110824 - 08/24/2011. METHOD: THE COMPLAINT RT042 MASKS HAVE NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE TO DATE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: WITHOUT THE RETURN OF THE COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. CONCLUSION: THE NASAL MASK HAS A HARD PLASTIC BASE WITH A SILICONE SEAL ENCLOSING FOAM AROUND THE OUTER EDGE OF THE BASE TO SEAL ONTO THE PATIENT. THE SEAL IS HELD ONTO THE BASE OF THE MASK BY A COMBINATION OF SILICONE CLIPS WITH AN INTERFERENCE FIT. ALL RT042 NASAL MASKS ARE VISUALLY INSPECTED PRIOR TO LEAVING PRODUCTION, ANY THAT FAIL THIS TEST ARE REJECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURER DATE: LOT 110726 - 07/26/2011; LOT 110823 - 08/23/2011; LOT 110824 - 08/24/2011. WE ARE CURRENTLY ENDEAVOURING TO RETRIEVE THE COMPLAINT DEVICES. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT RT042 NASAL MASKS WERE LEAKING THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT RT042 NASAL MASKS WERE LEAKING THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT RT042 NASAL MASKS WERE LEAKING. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL NASAL MASK BYG BYG FISHER & PAYKEL HEALTHCARE LTD RT042 110726 , 110823 , 110824

    Patients

    Seq Age Sex Outcome Treatment
    1