MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE INC. VITERA FULL FACE CPAP MASK WITH HEADGEAR; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2020

Event Type  Injury  

Event Description

The new fisher & paykel vitera full face cpap mask with headgear has a factory problem.The problem is that the hose is easily detached from the mask.Even a child can remove the hose from the mask.I am getting up without being able to breathe with the mask on my face and the hose on the floor.You don't have to put pressure on it to separate the mask from the hose.A month ago i contacted the manufacturer and still haven't received a response.You need to investigate this.Sleeping without the appropriate air pressure can cause serious health complications including death.Fda safety report id # (b)(4).

• Brand Name: VITERA FULL FACE CPAP MASK WITH HEADGEAR
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE INC.
• MDR Report Key: 10137726
• MDR Text Key: 194854656
• Report Number: MW5094909
• 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: 06/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 244