MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problem Epistaxis (4458)

Event Date 03/07/2024

Event Type  Injury  

Event Description

Patient with epistaxis with use of cpap (continuous positive airway pressure) humidifier.Reports cpap (continuous positive airway pressure) water gets too hot despite adjusting settings and water runs out too fast before the end of the night.Had to stop using cpap (continuous positive airway pressure) for a few months to see if it was a coincidence, but when he started using it again despite using saline nasal spray, he had the same symptoms.

• Brand Name: PHILIPS DREAMSTATION2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18897617
• MDR Text Key: 337777830
• Report Number: MW5152776
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 109 KG