MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS DREAM WEAR CPAP CUSHION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 3000001754311

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2022

Event Type  malfunction  

Event Description

Leak in cpap air requiring replacement of brand new cushion.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAM WEAR CPAP CUSHION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 13560708
• MDR Text Key: 285967938
• Report Number: MW5107558
• 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: 02/15/2022

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: 3000001754311
• Device Lot Number: 0301962496
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2022
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White