MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. DREAMSTATION AUTO CPAP WITH HEATED HUMIDIFIER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500H11

Device Problems Nonstandard Device (1420); Device Emits Odor (1425)

Patient Problem Aspiration/Inhalation (1725)

Event Date 04/15/2021

Event Type  malfunction  

Event Description

Ordered a dreamstation auto cpap from cpap.Com to replace my existing cpap.Immediately upon using, noticed a strong chemical smell from the unit through the face mask.Discontinued.Soon thereafter, the recall notice was issued.I have a confirmation number through philips, but despite sending them the uploaded data and no longer having a sleep physician, they keep losing the machine data and say i have to go to the doctor to get a new prescription, that they won't replace it without a prescription.Therefore, i asked for my money back.They said they'd make a note and someone would be in touch with me in 24-48 hours.It didn't happen.Their "patient portal" has zero information except that what "stage" you're in.Everything needs to be done over the phone, via call centers in other countries where scripts are followed but they have no understanding of what they're doing.I just want my (b)(6) back.The company i purchased from cpap.Com, says it's not liable and will not reimburse me either.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP WITH HEATED HUMIDIFIER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 15925108
• MDR Text Key: 304977905
• Report Number: MW5113643
• 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: 12/01/2022

1 Device was Involved in the Event

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: DSX500H11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2022
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White