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

Model Number	BC801-10
Medical Device Problem Codes	Leak/Splash (1354); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher and paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject bc801 infant nasal mask medium bcpap to f&p new zealand for 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) field representative that two bc801 infant nasal mask medium bcpap were not creating a seal during patient use.There were no reported patient consequences.
Event or Problem Description
A healthcare facility in ohio reported via a fisher & paykel healthcare (f&p) field representative that two bc801 infant nasal mask medium bcpap were not creating a seal during patient use.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4) section d4: serial number intentionally left blank as the information is not applicable.Section g4: no 510(k) number was included due to the subject device being exempt from pma pathway to regulatory approval.Method: the two subject units, bc801 infant nasal mask medium bcpap were received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Our investigation is thus based on the evaluation of the subject device, the information provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the subject devices were performed.The returned masks were observed to have a thinner nasal wall and misaligned at the parting line.This created a gap between the mask and flexitrunk and the inability to seal, thus confirming the reported fault.The supplier also confirmed that two pins of a moulding tool was replaced, it was noted that there was misalginment of the pins of the tool.Conclusion: our investigation concluded that the misalignment of the moulding tool pins caused the partial misalignment of the masks parting lines, and hence the wall thickness.The moulding tool pins have been replaced in november 2024 as a corrective action.Our user instructions which accompany the bubble cpap system state: - "use caution when positioning or disconnecting to the infant interface.Avoid excessive pull forces, sharp objects, and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement.".

• Brand Name: FISHER & 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20808224
• Report Number: 9611451-2024-00880
• Device Sequence Number: 9830898
• Product Code: BYG
• UDI-Device Identifier: 09420012432681
• UDI-Public: (01)09420012432681(10)2103161408(11)240529(17)270529
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 2103161408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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 Age: 7 DA
• Patient Sex: Unknown