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

Model Number	BC801-10
Medical Device Problem Codes	Gas/Air Leak (2946); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in san diego has 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 consequence as the mask was replaced immediately after noticing the reported failure.The healthcare facility further reported that they currently have ninety unused masks from two different batches.Fisher & paykel healthcare (f&p) has requested the healthcare facility to return all the masks for an investigation.
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 san diego has 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 consequence as the mask was replaced immediately after noticing the reported failure.The healthcare facility further reported that they currently have ninety unused masks from two different batches.Fisher & paykel healthcare (f&p) has requested the healthcare facility to return all the masks for an investigation.
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 complaint devices bc801-10 infant nasal mask medium bcpap were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photography provided by the customer and our knowledge of our product.Results: the customer reported that the bc801-10 infant nasal mask medium bcpap could not hold a seal and leaks.The provided photography and videography reports that the wall seems to be thinner on size medium masks when compared to size small masks and creates a gas pathway when bent inside the interface.Conclusion: without the complaint device, we are unable to determine the exact cause of the reported fault.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.".

• Brand Name: FISHER AND PAYKEL HEALTHCARE
• Common Device Name: MASK, OXYGEN
• 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: 20243278
• Report Number: 9611451-2024-00670
• Device Sequence Number: 17950773
• Product Code: BYG
• UDI-Device Identifier: 09420012432681
• UDI-Public: (01)09420012432681(10)2103109058(11)240430(17)270430
• 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): 08/19/2024

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: 2103109058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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