MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER AND PAYKEL HEALTHCARE; NASAL MASK

Model Number	BC801-10
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Section g4: pma/510(k) number: no 510(k) number was added in section g4 of the report because the device is a class 1 device and exempt from pma pathway to regulatory approval.Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the bc801-10 infant nasal mask medium bcpap could not hold a seal and leaks.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Section g4: pma/510(k) number: no 510(k) number was added in section g4 of the report because the device is a class 1 device and exempt from pma pathway to regulatory approval.Method: the subject devices bc801-10 infant nasal mask medium bcpap were returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.Our investigation is thus based on the evaluation of subject device, information provided by the healthcare facility and our knowledge of our product.Results: visual inspection of the subject masks revealed that its nasal walls were thinner.When connected to the flexitrunk tubing, the nasal part was observed to be squeezed and pinched which then created a gap between the subject mask and flexitrunk tubing.This resulted in the improper sealing when compared to the other masks of all sizes from production.It was further observed that the subject masks were misaligned at the parting line which could result in thinner walls.Further investigation has revealed that during servicing of the mold tool in (b)(6) 2024, the supplier has identified that two of the alignment pins were worn out.Conclusion: the reported malfunction was caused due to the misalignment of the mold tool pins resulting in the parting line of the medium-sized masks to be misaligned and hence causing the thinner walls at the mating part to the flexitrunk.The mold tool pins were replaced in (b)(6) 2024 as part of corrective action.The user instructions that accompany the flexitrunk infant interface illustrate in pictorial format the correct set-up and proper use of infant interfaces, including the nasal mask and nasal tubing.It also states the following: "connect prongs and mask to nasal tubing ensuring that it is inserted fully." "if using mask: connect to patient by placing mask around the nose.The mask should sit comfortably around the patient's nose.It must not occlude the nostrils or touch the septum and should not be over the lip or over the eyes." "check that all circuit connections are tight before use and after any adjustment.".
Event or Problem Description
A healthcare facility in san diego reported via a fisher & paykel healthcare (f&p) representative that the bc801-10 infant nasal mask medium bcpap could not hold a seal and leaks.There was no reported patient involvement.

• Brand Name: FISHER AND PAYKEL HEALTHCARE
• Common Device Name: NASAL MASK
• 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20803005
• Report Number: 9611451-2024-00874
• Device Sequence Number: 21200951
• Product Code: BYG
• UDI-Device Identifier: 09420012432681
• UDI-Public: (01)09420012432681(10)2103192764(11)240618(17)270618
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: BC801-10
• Device Catalogue Number: BC801-10
• Device Lot Number: 2103192764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown