MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION 2 AUTO CPAP ADVANCED; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION 2 AUTO CPAP ADVANCE

Patient Problem Sleep Dysfunction (2517)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

After receiving a replacement continuous positive airway pressure dreamstation 2 from philips respironics for my recalled dreamstation 1 i have noticed an anomaly occurring with the dreamstation 2.The reservoir tank water for humidification needs to be replaced at the least every two days.My original recalled dreamstation 1 would only need to be refilled every 7 days at the most.Also if the tank in the dreamstation 2 inadvertently runs dry during the night a very strong smell emits through the tubing to the extent that it wakes me from a sound sleep.If i refill the reservoir the smell dissipates.The humidification setting on the new unit is set the same as old dreamstation.Reference report: mw5152430.

• Brand Name: PHILIPS DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18856593
• MDR Text Key: 337248792
• Report Number: MW5152429
• 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: Patient
• Type of Report: Initial
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DREAMSTATION 2 AUTO CPAP ADVANCE
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CARVEDILOL 3.1MG.; LOSARTAN 50MG.; TAMSULOSIN .4MH.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White