MAUDE Adverse Event Report: FISHER &PAYKEL HEALTHCARE, INC. BREVIDA NASAL MASK PILLOW; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number BRE1MA

Patient Problem Discomfort (2330)

Event Date 12/02/2023

Event Type  malfunction  

Event Description

Cpap mask is malfunctioning.Made by fisher &paskel, "brevida nasal pillow mask" is the trade name.A component called a diffuser is out of tolerance and unintentionally falls off.It is small and difficult to find.It is an injected molded transparent clip that has distorted likely due to too quick a cooling cycle before ejection from the machine.Either that or poor tolerancing and certainly the qc did not catch it.This is the second mask with the same problem.The supplier (b)(4) replaced the first mask about 2 months ago and required me to send the defective mask back for onward shipping to fisher for diagnosis and resolution.Now in dealing with others in the same company who are not versed in fda regulations about defective medical devices are unwilling to provide me with another mask.They say that even with the diffuser off it still works.I have not found that to be the case.All the air leaks out without this restriction device, makes a loud hissing noise and the air is ejected at high velocity which is uncomfortable if it impinges on the face, neck or exposed skin.Please call them and let them know that the issue with the mask must be resolved for all users of these masks and that it's encumber on them to follow the correct procedures for reporting, identifying and resolving this problem at the source biomedical device manufacturer.Reference report: mw5149113.

• Brand Name: BREVIDA NASAL MASK PILLOW
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): FISHER &PAYKEL HEALTHCARE, INC.
• MDR Report Key: 18310485
• MDR Text Key: 330371299
• Report Number: MW5149112
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2023

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: BRE1MA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White