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

Device Problems Use of Incorrect Control/Treatment Settings (1126); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2023

Event Type  Injury  

Event Description

Yesterday i saw a long time patient of mine, pulmonary hypertension, chf, morbid obesity, severe osa, on home oxygen (4 lpm) and bipap/avaps.She needs epap 12, ipap 24.Philips sent her a new machine with no power cord or water chamber, and the settings were epap 4, ipap 25.So the settings were way too low.Because of the power cord and water chamber issue, she continued using her existing machine that had the correct settings.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16763269
• MDR Text Key: 313571346
• Report Number: MW5116749
• 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: Physician
• Type of Report: Initial
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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): Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American