MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS INC. DREAMSTATION 1 CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Aspiration/Inhalation (1725); Dyspnea (1816); Pulmonary Emphysema (1832)

Event Date 01/25/2024

Event Type  Injury  

Event Description

I had received the letter from philips about the dreamstation cpap recall 6-2021 and registered my device.I used the recalled philips dreamstation 1 cpap machine from (b)(6) 2019 until i received my replacement dreamstation 2 machine (b)(6) 2021.I noticed i was having shortness of breath at times and hoarseness in my voice, and had a chest x-ray (b)(6) 2024.It showed that my lungs are hyper-inflated suggesting emphysema.I have appointments with a pulmonologist and an ent specialist this month.I have always lived a healthy lifestyle.Never smoked, always exercised, ate healthy and watched my weight.I know this test result of emphysema is directly related to breathing in the toxic particles and fumes from the degraded c-pap foam.I'm worried that i may end up with some type of cancer from it also like other people have.The fact the philips knew it was unsafe prior to the recall and chose to still use it makes me very angry.It put our health and lives at risk.I'm afraid to even be using the replacement machine because of the fire hazard problems reported about it and if the new foam is really safe, and am seeing if i can get another cpap brand to use which i hope will be safer.

• Brand Name: DREAMSTATION 1 CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS INC.
• MDR Report Key: 18857124
• MDR Text Key: 337262801
• Report Number: MW5152443
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: 81 MG ASPIRIN AT BEDTIME.; COQ-10.; DREAMSTATION 2 REPLACEMENT C-PAP MACHINE.; EYE SUPPLEMENTS.; LATANAPROST EYE DROPS.; MELATONIN OCCASIONALLY AT BEDTIME.; METOPROLOL.; MULTI VITAMIN.; OCCASIONALLY ANXIO-CALM HERBAL SUPPLEMENT IF I CAN'T FALL ASLEEP.; OMEGA 3.; PRAVASTATIN.; T3-LIOTHYRONINE.; TRANSFER FACTOR IMMUNE SUPPORT.; VITAMIN C.; VITAMIN D.
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White