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

Model Number DSX700 DREAM STATION AUTO BI-PAP

Device Problems Nonstandard Device (1420); Device Emits Odor (1425); Infusion or Flow Problem (2964)

Patient Problem Aspiration/Inhalation (1725)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Philips recalled my cpap machine a few years ago for faulty, cancer-causing, melting foam inside the machine designed to silence the machine as much as possible.Often, i've been woken up because of the cpap air i was breathing that smelt burnt like.The water chamber often runs dry.My device registration confirmation number is (b)(4).Philips respironics recall contact # is (b)(6).Due to my heart attack and having a heart stent, asthma, etc.I was put on their priority list, yet 2 years plus into this recall, i've not had my machine replaced.Can you inquire about this medical device problem? i fear for my health.Thank you.My device is registered, but my order is not yet processed.It should have been replaced by now.Please advise.Thank you (b)(6).Fda safety report id# (b)(4).

• Brand Name: CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15632308
• MDR Text Key: 302063733
• Report Number: MW5112711
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700 DREAM STATION AUTO BI-PAP
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CPAP IS THE ONLY MEDICAL DEVICE I USE.
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White