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

Model Number DREAMSTATION II

Device Problems Thermal Decomposition of Device (1071); Nonstandard Device (1420); Smoking (1585)

Patient Problem Aspiration/Inhalation (1725)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

The patient obtained a philips respironics dreamstation 2 cpap through the (b)(6), that was a replacement for his previously recalled philips respironics dreamstation cpap.On the night he used the cpap for the first time (b)(6) 2022, he reports he woke up because "smoke poured into my mask.And the machine burned up.I thought i was in a house fire." his dreamstation 2 was subsequently exchanged for a resmed brand cpap instead.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION II
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15537104
• MDR Text Key: 301191631
• Report Number: MW5112398
• 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: 09/29/2022
• 2 Devices were Involved in the Event: 1 2

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: DREAMSTATION II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White