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

Device Problems Disconnection (1171); Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

Cpap face mask tubing comes out very easily.Have been using same brand this is third one of these i have ordered.The third one, this tube, disconnects from o-ring overly easy compared to the other two.This happened multiple times, over multiple nights.I reached out to durable medical equipment provider and advised them.They are sending a replacement.They advise they fill out a form when they do a replacement and the manufacturer is notified.The manufacturer is resmed.Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on 07/19/2022, for report mw5110322.I accidentally submitted this as being a resmed product but the product is actually evora nasal manufactured by fisher & paykel healthcare.I wanted to advise you so that my voluntary report can be amended.

• Brand Name: EVORA NASAL
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.
• MDR Report Key: 14695578
• MDR Text Key: 294252446
• Report Number: MW5110322
• 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,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: REMED SLEEP APNEA DEVICE
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White