MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ZEST Q PLUS NASAL MASK; BZD

Model Number 400446

Device Problems Device Issue (2379); Human-Device Interface Problem (2949)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint 400446u zest q plus nasal mask was not returned to fisher & paykel healthcare (fph) for investigation.Our investigation is therefore based on the description of events, information provided by the distributor and our knowledge of the product.The patient has been a user of nasal cpap masks for 20 years and has used 7 different masks since 1997: (b)(6) 1997 to (b)(6) 2001 - resmed nasal mask soft series size m.(b)(6) 2001 - (b)(6) 2009 - resmed nasal mask ultra-mirage size l.(b)(6) 2009 - fph nasal mask hc405.(b)(6) 2009 - (b)(6) 2012 - resmed nasal mask micro size l.(b)(6) 2012 - (b)(6) 2014 - resmed nasal mask micro size m.(b)(6) 2014 - air liquide medical systems - nasal mask respireo size xl.(b)(6) 2014 - (b)(6) 2016 - fph 400446u zest q plus nasal mask.From (b)(6) 2016 - resmed facial mask quattro air size l (however the patient has returned to using his zest q plus nasal mask).The following information was also reported to fph: the patient had allegedly experienced gum pain since the start of his cpap therapy however this was never mentioned prior to the current complaint.The distributor has since provided the patient with a full face mask however the patient has returned to using his zest q plus nasal mask.The patient visited his dentist in (b)(6) 2015 stating that his upper teeth had moved inwards and was referred to an orthodontist.It was reported that the patient's teeth were not loose but the implant region was deformed.An operation was performed in (b)(6) 2016 where the patient received new upper and lower false teeth.The 400446u zest q plus nasal mask is intended to be used by individuals who have been diagnosed by a physician as requiring cpap or bi-level ventilator treatment.A general clinical literature search revealed one case of localised gingival recession caused by a cpap mask.No further details were available regarding duration of therapy and mask model in this single case.When a clinical literature search on the long term side effects of cpap therapy was conducted, no specific mention of dental issues reported by the patient was found.Facial marks after cpap mask usage is common and is a known event in clinical literature.The patient has had 7 different nasal masks since 1997, in which therapy was received via non-fph masks approximately 88% of the time.The complaint 400446u zest q plus nasal mask had only been used for 7.6% of the therapy period.In addition, the clinical literature reviewed has also indicated a link between gum disease/gum recession in patients with diabetes.Based on the reasons outlined above, we are unable to determine the possible root causes of the reported event.(b)(4).Our user instructions for the zest q plus state: 'discontinue use if discomfort or irritation occurs, and consult your healthcare provider.' 'fitting your mask: if necessary, tighten the lower straps to eliminate any leaks (avoid over-tightening the straps).'.

Event Description

A patient reported via a distributor that the "gums of all his upper teeth have receded/all his upper teeth are loose".The patient had been using a 400446u zest q nasal mask between (b)(6) 2014 - (b)(6) 2016.It was also reported that the dentist could allegedly tell the patient was a mask user based on facial marks/lines.The patient has been a user of nasal cpap masks for approximately 20 years and has used 7 different masks since 1997.The patient was also diagnosed in 2004 with diabetes.

• Brand Name: ZEST Q PLUS NASAL MASK
• Type of Device: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5705655
• MDR Text Key: 46779671
• Report Number: 9611451-2016-00252
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 400446
• Device Catalogue Number: 400446
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1